KNIGHT LIGHT NONLUBRICATED CONDOM

Condom

GLOBAL PROTECTION CORP.

The following data is part of a premarket notification filed by Global Protection Corp. with the FDA for Knight Light Nonlubricated Condom.

Pre-market Notification Details

Device IDK960552
510k NumberK960552
Device Name:KNIGHT LIGHT NONLUBRICATED CONDOM
ClassificationCondom
Applicant GLOBAL PROTECTION CORP. 116 VILLAGE BLVD. SUITE 200 Princeton,  NJ  08540 -5799
ContactThomas Becze
CorrespondentThomas Becze
GLOBAL PROTECTION CORP. 116 VILLAGE BLVD. SUITE 200 Princeton,  NJ  08540 -5799
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-08
Decision Date1997-11-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850002174700 K960552 000
00850002174649 K960552 000

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