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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 K902772
Device Name PLEASURE PLUS
Applicant
MEDIMIX PRODUCTS, INC.
MCKENNA, CONNER & CUNEO
1575 EYE STREET, N.W.
WASHINGTON,  DC  20005
Applicant Contact MARTIN J HAHN
Correspondent
MEDIMIX PRODUCTS, INC.
MCKENNA, CONNER & CUNEO
1575 EYE STREET, N.W.
WASHINGTON,  DC  20005
Correspondent Contact MARTIN J HAHN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received06/22/1990
Decision Date 08/14/1991
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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