The following data is part of a premarket notification filed by American Laboratories, Inc. with the FDA for Duet (condoms).
| Device ID | K880185 |
| 510k Number | K880185 |
| Device Name: | DUET (CONDOMS) |
| Classification | Condom |
| Applicant | AMERICAN LABORATORIES, INC. 25 HUTCHESON PLACE Lynbrook, NY 11563 |
| Contact | Jed Forman |
| Correspondent | Jed Forman AMERICAN LABORATORIES, INC. 25 HUTCHESON PLACE Lynbrook, NY 11563 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-15 |
| Decision Date | 1988-06-17 |