The following data is part of a premarket notification filed by Carter Products with the FDA for Trojan (tm-tbd) Condom.
| Device ID | K912901 |
| 510k Number | K912901 |
| Device Name: | TROJAN (TM-TBD) CONDOM |
| Classification | Condom |
| Applicant | CARTER PRODUCTS HALF ACRE RD. Cranbury, NJ 08512 |
| Contact | Stephen Kolakowsky |
| Correspondent | Stephen Kolakowsky CARTER PRODUCTS HALF ACRE RD. Cranbury, NJ 08512 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-02 |
| Decision Date | 1992-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80022600002358 | K912901 | 000 |
| 00022600999409 | K912901 | 000 |
| 80022600927422 | K912901 | 000 |
| 80022600999535 | K912901 | 000 |
| 80022600001436 | K912901 | 000 |
| 80022600001412 | K912901 | 000 |
| 00022600973201 | K912901 | 000 |
| 00022600927204 | K912901 | 000 |