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 |