The following data is part of a premarket notification filed by Avid N.i.t., Inc. with the FDA for N.i.t., Inc. Needle Guiding Template.
| Device ID | K973638 |
| 510k Number | K973638 |
| Device Name: | N.I.T., INC. NEEDLE GUIDING TEMPLATE |
| Classification | System, Applicator, Radionuclide, Manual |
| 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 | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-24 |
| Decision Date | 1997-12-23 |