The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Once Tm.
| Device ID | K800162 |
| 510k Number | K800162 |
| Device Name: | ONCE TM |
| Classification | Diaphragm, Contraceptive (and Accessories) |
| Applicant | G.D. SEARLE AND CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HDW |
| CFR Regulation Number | 884.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-25 |
| Decision Date | 1980-02-11 |