The following data is part of a premarket notification filed by Omega-med Intl., Inc. with the FDA for Omed Silicone Loops.
| Device ID | K810260 |
| 510k Number | K810260 |
| Device Name: | OMED SILICONE LOOPS |
| Classification | Instrument, Surgical, Disposable |
| Applicant | OMEGA-MED INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-30 |
| Decision Date | 1981-02-26 |