The following data is part of a premarket notification filed by Thai Nippon Rubber Industry Co., Ltd. with the FDA for Latex Condom.
| Device ID | K994095 |
| 510k Number | K994095 |
| Device Name: | LATEX CONDOM |
| Classification | Condom |
| Applicant | THAI NIPPON RUBBER INDUSTRY CO., LTD. 1219 LITTLE CREEK RD. Durham, NC 27713 |
| Contact | Eli J Carter |
| Correspondent | Eli J Carter THAI NIPPON RUBBER INDUSTRY CO., LTD. 1219 LITTLE CREEK RD. Durham, NC 27713 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-03 |
| Decision Date | 2000-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850281004019 | K994095 | 000 |
| 00850016109156 | K994095 | 000 |
| 00850016109088 | K994095 | 000 |
| 00850016109019 | K994095 | 000 |
| 00850281004088 | K994095 | 000 |
| 00850281004187 | K994095 | 000 |
| 00850281004323 | K994095 | 000 |
| 00850281004354 | K994095 | 000 |
| 00850281004309 | K994095 | 000 |
| 00850016109712 | K994095 | 000 |