LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)

Condom

SURETEX, LTD.

The following data is part of a premarket notification filed by Suretex, Ltd. with the FDA for Latex Condoms W/spermicidal Lubricant (nonoxynol-9).

Pre-market Notification Details

Device IDK942858
510k NumberK942858
Device Name:LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)
ClassificationCondom
Applicant SURETEX, LTD. 71 SOI SAP, SIPRAYA, BANGKOK 10500, Thailand,  TH 10500
ContactAshok Mukherjee
CorrespondentAshok Mukherjee
SURETEX, LTD. 71 SOI SAP, SIPRAYA, BANGKOK 10500, Thailand,  TH 10500
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-16
Decision Date1995-05-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00070907222102 K942858 000
00070907216101 K942858 000
00070907212240 K942858 000
00070907212127 K942858 000
00070907208106 K942858 000
30070907055008 K942858 000
80070907695520 K942858 000
18859798104945 K942858 000

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