The following data is part of a premarket notification filed by Omega-med Intl., Inc. with the FDA for Omed Silicone Instrument Covers.
| Device ID | K810883 |
| 510k Number | K810883 |
| Device Name: | OMED SILICONE INSTRUMENT COVERS |
| Classification | Instrument, Surgical, Disposable |
| Applicant | OMEGA-MED INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-01 |
| Decision Date | 1981-04-23 |