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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 K904453
Device Name LABELLING MODIFICATION TO MAXX PLUS
Applicant
MAYER LABORATORIES
231 FALLON ST.
OAKLAND,  CA  94607
Applicant Contact DAVID P MAYER
Correspondent
MAYER LABORATORIES
231 FALLON ST.
OAKLAND,  CA  94607
Correspondent Contact DAVID P MAYER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/27/1990
Decision Date 11/23/1990
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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