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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K946376
Device Name MAXX
Applicant
MAYER LABORATORIES
231 FALLON ST.
OAKLAND,  CA  94607
Applicant Contact DABID MAYER
Correspondent
MAYER LABORATORIES
231 FALLON ST.
OAKLAND,  CA  94607
Correspondent Contact DABID MAYER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/14/1994
Decision Date 09/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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