CELESTIN ENDO-OESOPHAGEAL TUBE AND PILOT-BOUGIE MANUFACTURED BY AMBLETIN LTD.

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Request for Information Form	Contact Information
Company Name	AMBLETIN LTD.
Address	P.O. BOX 1
City, State, Zip	TETBURY, GLOS.,
Country	UK
FDA Owner/Operator Phone	--
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	FAT
FDA Classification Name	BOUGIE, ESOPHAGEAL, AND GASTROINTESTINAL, GASTRO-UROLOGY
FDA Device Classification Code	Standards
FDA Regulation Number	876.5365
FDA Common Generic Name	BOUGIE, OESOPHAGEAL & GASTROINTESTINAL GASTRO-UROLOGY
FDA Proprietary Device Name	CELESTIN ENDO-OESOPHAGEAL TUBE AND PILOT-BOUGIE
FDA Owner / Operator Number	8010357
FDA Owner / Operator Name	AMBLETIN LTD.
FDA Establishment Registration Number	8010357
FDA Registered Establishment Name	AMBLETIN LTD.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	AESCULAP, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US 800-258-1946 / 610-984-9074	VARIOUS	VARIOUS
2	COLOPLAST MANUFACTURING FRANCE, SAS USINE DU PONTET BP 89 SARLAT, 24203 FR 45-49-111111 / 612-302-4992	FILLIFORMS, FOLLOWERS, BOUGIES	FILLIFORMS, FOLLOWERS, BOUGIES
3	COMBINED INSTRUMENTS (PVT.), LTD. 13-A MODEL TOWN, UGOKI SAILKOT, PK 04-32-510243 / 05-24-510243	BOUGIE, ESOPHAGEAL, AND GASTROINTESTINAL, GASTRO-UROLOGY	SAME
4	DEPUY INTL., LTD. ST. ANTHONY'S RD. LEEDS, LS11 8DT UK 574-267-8143 4906 / 574-371-4906	MULTIPLE	VARIOUS BOUGES
5	DYNAMIC SURGICAL (PVT) LTD WAZIRABAD RD UGOKI SIALKOT, PK 92-52-3510268 / 92-52-3510268	BOUGIE, ESOPHAGEAL AND GASTROINTESTINAL GASTRO UROLOGY	BOUGIE, ESOPHAGEAL AND GASTROINTESTINAL GASTRO UROLOGY
6	MEDOVATIONS, INC. 102 EAST KEEFE AVE. MILWAUKEE, WI 53212 US 414-265-7620 / 414-265-7620	M-FLEX BLUE SILICONE BOUGIE	ESOPHAGEAL BOUGIE
7	STRYKER ENDOSCOPY 5900 OPTICAL CT. SAN JOSE, CA 95138 US 269-385-2600 / 408-754-2124	INFRVISION ESOPHAGEAL KIT	E-KIT
8	SURGICON (PVT) LTD. P.O. BOX 244 KHADIM ALI RD. SIALKOT, PUNJAB, PK 92-432-262530 31 / 92-432-262531 32	BOUGIE ESOPHAGEAL AND GASTROINTES-TINAL	BOUGIE ESOPHAGEAL AND GASTROINTES-TINAL
9	TELEFLEX MEDICAL 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US 919-544-8000 / 919-433-4829	MULTIPLE GASTRO-UROLOGY ESOPHAGEAL AND GASTROINTESTINAL BOUGIE	VARIOUS TYPES OF GASTRO-UROLOGY ESOPHAGEAL AND GASTROINTESTINAL BOUGIES