EZ-ON BI-DIRECTIONAL MANUFACTURED BY MAYER LABORATORIES

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Request for Information Form	Contact Information
Company Name	MAYER LABORATORIES
Address	1950 ADDISON STREET, SUITE 101
City, State, Zip	BERKELEY, CA 94704
Country	US
FDA Owner/Operator Phone	510-229-5300
FDA Medical Specialty Code	OB - Obstetrics/Gynecology
FDA Product Code	MOL
FDA Classification Name	CONDOM, SYNTHETIC
FDA Device Classification Code	Standards
FDA Regulation Number	884.5300
FDA Common Generic Name	PLASTIC CONDOM, POLYURETHANE CONDOM
FDA Proprietary Device Name	EZ-ON BI-DIRECTIONAL
FDA Owner / Operator Number	2938651
FDA Owner / Operator Name	MAYER LABORATORIES
FDA Establishment Registration Number	2938651
FDA Registered Establishment Name	MAYER LABORATORIES
FDA Operation Code(s)	MS - Specification Developer RR - Repackager/Relabeller
FDA Listing Date	02-11-04
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	CHURCH & DWIGHT VIRGINIA CO., INC. 1851 TOUCHSTONE RD. COLONIAL HEIGHTS, VA 23834 US 609-279-7748 / 609-279-7748	MULTIPLE NON-LATEX CONDOMS	CONDOM NON-LATEX
2	NAVAJO MFG. CO. 5330 FOX ST. DENVER, CO 80216 US 303-292-3090 / 303-292-3090 259	MULTIPLE	CONDOM
3	ROCK-TENN CONVERTING COMPANY 1090 THOMAS BUSH MEMORIAL HWY. PENNSAUKEN, NJ 08110 US 336-661-7173 / 856-438-2200	TROJAN SUPRA	POLYURETHANE CONDOM WITH NONOXYNOL-9
4	SAGAMI MANUFACTURERS SDN.BHD., BATU GAJAH FACTORY PLOT 29, LORONG BEMBAN 4, ESTET PERINDUSTRIAN BEMBAN JALAN BEMBAN, BATU GAJAH,PERAK, 31000 MY 605-366-9018 / 605-366-9018	MULTIPLE	CONDOM, NON-LATEX
5	SSL AMERICAS DISTRIBUTION CENTER 201 SCHMID PLAZA RD. ANDERSON, SC 29624 US 770-582-2174 / 770-582-2174	AVANTI	NON-LATEX CONDOM
6	TTK - LIG LTD. 65/2 KOTHAPURI NATHAM RD. THIRUVANDAR KOIL PONDICHERRY, 605102 IN 44-161-638 2572 / 770-582-2152	DUREX	NON-LATEX CONDOM