The following data is part of a premarket notification filed by Avid N.i.t., Inc. with the FDA for Reganes Spinal Needle (various).
| Device ID | K971645 |
| 510k Number | K971645 |
| Device Name: | REGANES SPINAL NEEDLE (VARIOUS) |
| Classification | Needle, Spinal, Short Term |
| Applicant | AVID N.I.T., INC. 917 KLOSTERMAN RD. EAST Tarpon Springs, FL 34689 |
| Contact | Joseph E Harms |
| Correspondent | Joseph E Harms AVID N.I.T., INC. 917 KLOSTERMAN RD. EAST Tarpon Springs, FL 34689 |
| Product Code | MIA |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-05 |
| Decision Date | 1997-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20809160061531 | K971645 | 000 |
| 20809160323691 | K971645 | 000 |
| 20809160323684 | K971645 | 000 |
| 20809160323677 | K971645 | 000 |
| 20809160323660 | K971645 | 000 |
| 20809160323646 | K971645 | 000 |
| 20809160323639 | K971645 | 000 |
| 20809160323622 | K971645 | 000 |
| 20809160323615 | K971645 | 000 |
| 20809160323707 | K971645 | 000 |
| 20809160002114 | K971645 | 000 |
| 20809160002121 | K971645 | 000 |
| 20809160057367 | K971645 | 000 |
| 20809160004224 | K971645 | 000 |
| 20809160002916 | K971645 | 000 |
| 20809160002862 | K971645 | 000 |
| 20809160002855 | K971645 | 000 |
| 20809160002282 | K971645 | 000 |
| 20809160002251 | K971645 | 000 |
| 20809160002244 | K971645 | 000 |
| 20809160323509 | K971645 | 000 |