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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom, Synthetic
510(k) Number K001974
Device Name EZ-ON CONDOM
Applicant
Mayer Laboratories
646 Kennedy St., Bldg. C
Oakland,  CA  94606
Applicant Contact DAVID P MAYER
Correspondent
Mayer Laboratories
646 Kennedy St., Bldg. C
Oakland,  CA  94606
Correspondent Contact DAVID P MAYER
Regulation Number884.5300
Classification Product Code
MOL  
Date Received06/29/2000
Decision Date 10/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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