The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Kirwan Irrigation/aspiration Handpiece.
| Device ID | K930113 |
| 510k Number | K930113 |
| Device Name: | KIRWAN IRRIGATION/ASPIRATION HANDPIECE |
| Classification | Cannula, Ophthalmic |
| 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 | HMX |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-11 |
| Decision Date | 1994-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841019109762 | K930113 | 000 |
| 00841019103449 | K930113 | 000 |
| 00841019103456 | K930113 | 000 |
| 00841019103463 | K930113 | 000 |
| 00841019103470 | K930113 | 000 |
| 00841019103487 | K930113 | 000 |
| 00841019103494 | K930113 | 000 |
| 00841019103500 | K930113 | 000 |
| 00841019103517 | K930113 | 000 |
| 00841019103432 | K930113 | 000 |