The following data is part of a premarket notification filed by Chinteik Hygiene Products Co.,ltd. with the FDA for Condom (rubber) Contraceptive.
Device ID | K893039 |
510k Number | K893039 |
Device Name: | CONDOM (RUBBER) CONTRACEPTIVE |
Classification | Condom |
Applicant | CHINTEIK HYGIENE PRODUCTS CO.,LTD. 60/50 NAVANAKORN IND. ESTATE ZONE 2, PHAHOLYOTHIN RD. Pathumthani, TH 12120 |
Contact | Nganthawe |
Correspondent | Nganthawe CHINTEIK HYGIENE PRODUCTS CO.,LTD. 60/50 NAVANAKORN IND. ESTATE ZONE 2, PHAHOLYOTHIN RD. Pathumthani, TH 12120 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-24 |
Decision Date | 1990-05-04 |