The following data is part of a premarket notification filed by Avid Medical, Inc. with the FDA for Avid-nit Cervical Regional Anesthesia Needle.
| Device ID | K000117 |
| 510k Number | K000117 |
| Device Name: | AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE |
| Classification | Set, Anesthesia, Paracervical |
| Applicant | AVID MEDICAL, INC. 9000 WESTMONT DR. STONEHOUSE COMMERCE PARK Toano, VA 23168 |
| Contact | Sean F Shemanski |
| Correspondent | Sean F Shemanski AVID MEDICAL, INC. 9000 WESTMONT DR. STONEHOUSE COMMERCE PARK Toano, VA 23168 |
| Product Code | HEE |
| CFR Regulation Number | 884.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-14 |
| Decision Date | 2000-04-13 |