The following data is part of a premarket notification filed by Namic with the FDA for Stopcocks, Manifolds.
| Device ID | K782095 |
| 510k Number | K782095 |
| Device Name: | STOPCOCKS, MANIFOLDS |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | NAMIC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-18 |
| Decision Date | 1979-01-23 |