The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Irrigation/aspiration Tubing Set.
| Device ID | K925621 |
| 510k Number | K925621 |
| Device Name: | IRRIGATION/ASPIRATION TUBING SET |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | KIRWAN SURGICAL PRODUCTS, INC. 83 E. WATER ST. P.O. BOX 545 Rockland, MA 02370 |
| Contact | Dana A Oliver |
| Correspondent | Dana A Oliver KIRWAN SURGICAL PRODUCTS, INC. 83 E. WATER ST. P.O. BOX 545 Rockland, MA 02370 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-06 |
| Decision Date | 1993-05-07 |