The following data is part of a premarket notification filed by Avid N.i.t., Inc. with the FDA for N,i.t., Inc. Automatic Cutting Biopsy Needle.
| Device ID | K983218 |
| 510k Number | K983218 |
| Device Name: | N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE |
| Classification | Biopsy Needle |
| Applicant | AVID N.I.T., INC. 390 SCARLET BLVD. Oldsmar, FL 34677 |
| Contact | Joseph E Harms |
| Correspondent | Joseph E Harms AVID N.I.T., INC. 390 SCARLET BLVD. Oldsmar, FL 34677 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-14 |
| Decision Date | 1998-11-06 |