The following data is part of a premarket notification filed by Universal Trade, Inc. with the FDA for Condoms.
| Device ID | K880819 |
| 510k Number | K880819 |
| Device Name: | CONDOMS |
| Classification | Condom |
| Applicant | UNIVERSAL TRADE, INC. 22 WEST PUTNAM AVE. Greenwich, CT 06830 |
| Contact | Edward J Aaron |
| Correspondent | Edward J Aaron UNIVERSAL TRADE, INC. 22 WEST PUTNAM AVE. Greenwich, CT 06830 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-26 |
| Decision Date | 1989-08-11 |