The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Namic Dual Backcheck Valve.
| Device ID | K884408 |
| 510k Number | K884408 |
| Device Name: | NAMIC DUAL BACKCHECK VALVE |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Contact | Robert E Franklin |
| Correspondent | Robert E Franklin NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-19 |
| Decision Date | 1989-01-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965640009251 | K884408 | 000 |
| 20193489058939 | K884408 | 000 |