The following data is part of a premarket notification filed by Omega-med Intl., Inc. with the FDA for Omed Disposable Bulldog.
| Device ID | K813499 |
| 510k Number | K813499 |
| Device Name: | OMED DISPOSABLE BULLDOG |
| Classification | Clamp, Vascular |
| Applicant | OMEGA-MED INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-14 |
| Decision Date | 1981-12-29 |