The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Namic Chiba Aspiration Biopsy Needle.
| Device ID | K864800 |
| 510k Number | K864800 |
| Device Name: | NAMIC CHIBA ASPIRATION BIOPSY NEEDLE |
| Classification | Needle, Aspiration And Injection, Disposable |
| 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 | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-09 |
| Decision Date | 1987-02-06 |