PROVOX SILICONE GLUE MANUFACTURED BY ATOS MEDICAL AB

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Request for Information Form	Contact Information
Company Name	ATOS MEDICAL AB
Address	KRAFTGATAN 8
City, State, Zip	HORBY,
Country	SW
FDA Owner/Operator Phone	46-415-198 00
FDA Medical Specialty Code	SU - General Plastic Surgery
FDA Product Code	GBJ
FDA Classification Name	PROSTHESIS, ADHESIVE, EXTERNAL
FDA Device Classification Code	General Controls
FDA Regulation Number	878.3750
FDA Common Generic Name	EXTERNAL ADHESIVE FOR PROSTHESIS
FDA Proprietary Device Name	PROVOX SILICONE GLUE
FDA Owner / Operator Number	8032044
FDA Owner / Operator Name	ATOS MEDICAL AB
FDA Establishment Registration Number	8032044
FDA Registered Establishment Name	ATOS MEDICAL AB
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	05-20-03
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	AMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH KAPELLENWEG 36 RAUBLING, BAVARIA, D-83064 GM 49-80-358710 / 49-80-35871152	AMOENA CONTACT BREAST FORMS, MULTIPLE	AMOENA CONTACT BREAST FORMS, VARIOUS TYPES & SIZES
2	DEPUY INTL., LTD. ST. ANTHONY'S RD. LEEDS, LS11 8DT UK 574-267-8143 4906 / 574-371-4906	SILICONE ADHESIVE	SILICONE ADHESIVE
3	EYEMEE BEAUTY WORLD RM.602,OJU B/D YOKSAM-DONG, GANGNAM-GU SEOUL, 135-080 KS 82-2-508-0797 / 82-2-34719008	MAXI GLUE	ADHESIVE
4	FACTOR, II, INC. 5642 WHITE MOUNTAIN AVE. LAKESIDE, AZ 85929 US 928-537-8387 / 928-537-8387 224	ADHESIVE	ADHESIVE
5	HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. SKOKIE, IL 60076 US 847-679-3400 / 847-679-3400	TAC	TAC
6	NEARLY ME TECHNOLOGIES, INC. 3630 SOUTH I-35, SUITE A WACO, TX 76706 US 254-662-1752 / 254-662-1752 229	NEARLY ME SILICONE SECURITY STRIPS	SILICONE PROSTHESIS ADHESIVE
7	PLASTODENT 2881 MIDDLETOWN RD. BRONX, NY 10461 US 718-792-3554 / 718-792-3554	PLASTODENT DENTAL IMPRESSION ADHESIVE	DENTAL IMPRESSION ADHESIVE
8	SMITHS MEDICAL ASD, INC. 5700 WEST 23RD AVE. GARY, IN 46406 US 114-420-8-458-3232 / 614-791-5568	LIQUID SILICONE ADHESIVE	LIQUID SILICONE ADHESIVE
9	UROCARE PRODUCTS, INC. 2735 MELBOURNE AVE. POMONA, CA 91767 US 909-621-6013 / 909-621-6013 15	URO-BOND SILICONE ADHESIVE	SILICONE ADHESIVE, EXTERNAL USE ONLY