The following data is part of a premarket notification filed by Nusurg, Inc. with the FDA for Avitene Dispenser Syringe.
| Device ID | K924517 |
| 510k Number | K924517 |
| Device Name: | AVITENE DISPENSER SYRINGE |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | NUSURG, INC. 7432 JAGER COURT Cincinnati, OH 45230 |
| Contact | Dennis R Lackey |
| Correspondent | Dennis R Lackey NUSURG, INC. 7432 JAGER COURT Cincinnati, OH 45230 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-04 |
| Decision Date | 1993-10-27 |