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 |