The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Namic Cournand Style Introducer Needle.
| Device ID | K871377 |
| 510k Number | K871377 |
| Device Name: | NAMIC COURNAND STYLE INTRODUCER NEEDLE |
| Classification | Trocar |
| Applicant | NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Contact | Eamonn P Hobbs |
| Correspondent | Eamonn P Hobbs NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-07 |
| Decision Date | 1987-05-07 |