The following data is part of a premarket notification filed by Omser Sv., Inc. with the FDA for Manifold Clamps.
| Device ID | K852118 |
| 510k Number | K852118 |
| Device Name: | MANIFOLD CLAMPS |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | OMSER SV., INC. 319 E. 17TH. AVE. Colubmus, OH 43201 |
| Contact | Sekula Vulic |
| Correspondent | Sekula Vulic OMSER SV., INC. 319 E. 17TH. AVE. Colubmus, OH 43201 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-15 |
| Decision Date | 1985-06-06 |