CONDOM (RUBBER) CONTRACEPTIVE

Condom

CHINTEIK HYGIENE PRODUCTS CO.,LTD.

The following data is part of a premarket notification filed by Chinteik Hygiene Products Co.,ltd. with the FDA for Condom (rubber) Contraceptive.

Pre-market Notification Details

Device IDK893039
510k NumberK893039
Device Name:CONDOM (RUBBER) CONTRACEPTIVE
ClassificationCondom
Applicant CHINTEIK HYGIENE PRODUCTS CO.,LTD. 60/50 NAVANAKORN IND. ESTATE ZONE 2, PHAHOLYOTHIN RD. Pathumthani,  TH 12120
ContactNganthawe
CorrespondentNganthawe
CHINTEIK HYGIENE PRODUCTS CO.,LTD. 60/50 NAVANAKORN IND. ESTATE ZONE 2, PHAHOLYOTHIN RD. Pathumthani,  TH 12120
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-24
Decision Date1990-05-04

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