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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 K960552
Device Name KNIGHT LIGHT NONLUBRICATED CONDOM
Applicant
GLOBAL PROTECTION CORP.
116 VILLAGE BLVD.
SUITE 200
PRINCETON,  NJ  08540 -5799
Applicant Contact THOMAS BECZE
Correspondent
GLOBAL PROTECTION CORP.
116 VILLAGE BLVD.
SUITE 200
PRINCETON,  NJ  08540 -5799
Correspondent Contact THOMAS BECZE
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/08/1996
Decision Date 11/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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