SAXON ULTRA THIN

Condom

SAFETEX CORP.

The following data is part of a premarket notification filed by Safetex Corp. with the FDA for Saxon Ultra Thin.

Pre-market Notification Details

Device IDK900360
510k NumberK900360
Device Name:SAXON ULTRA THIN
ClassificationCondom
Applicant SAFETEX CORP. 16101 CONTINENTAL BLVD. Colonial Heights,  VA  23834
ContactRonald L Davis
CorrespondentRonald L Davis
SAFETEX CORP. 16101 CONTINENTAL BLVD. Colonial Heights,  VA  23834
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-25
Decision Date1990-04-02

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