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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 K904375
Device Name KIMONO PLUS
Applicant
MAYER LABORATORIES
231 FALLON ST.
OAKLAND,  CA  94607
Applicant Contact DAVID MAYER
Correspondent
MAYER LABORATORIES
231 FALLON ST.
OAKLAND,  CA  94607
Correspondent Contact DAVID MAYER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/25/1990
Decision Date 11/26/1990
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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