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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 K882009
Device Name KING KONDOM (CONDOM)
Applicant
KING KONDOM PRODUCTS, INC.
301 - 2245 WEST BROADWAY
VANCOUVER, B.C.
CANADA,  CA V6K 2E4
Applicant Contact PHILIP M SNELL
Correspondent
KING KONDOM PRODUCTS, INC.
301 - 2245 WEST BROADWAY
VANCOUVER, B.C.
CANADA,  CA V6K 2E4
Correspondent Contact PHILIP M SNELL
Regulation Number884.5300
Classification Product Code
HIS  
Date Received05/13/1988
Decision Date 09/21/1988
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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