CONDOMS (RUBBER CONTRACEPTIVES)

Condom

SURETEX, LTD.

The following data is part of a premarket notification filed by Suretex, Ltd. with the FDA for Condoms (rubber Contraceptives).

Pre-market Notification Details

Device IDK910284
510k NumberK910284
Device Name:CONDOMS (RUBBER CONTRACEPTIVES)
ClassificationCondom
Applicant SURETEX, LTD. C/O G. PREMJEE (U.S.A.), INC. P.O. BOX 1084 Avondale,  AZ  85323
ContactAnil Utamchandani
CorrespondentAnil Utamchandani
SURETEX, LTD. C/O G. PREMJEE (U.S.A.), INC. P.O. BOX 1084 Avondale,  AZ  85323
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-23
Decision Date1991-06-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60761236901128 K910284 000
00761236110184 K910284 000
00761236110207 K910284 000
00761236110214 K910284 000
00761236110238 K910284 000
00761236110245 K910284 000
00761236110269 K910284 000
00761236110276 K910284 000
00761236110290 K910284 000
60761236901074 K910284 000
60761236901098 K910284 000
00761236901119 K910284 000
00761236110160 K910284 000

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