The following data is part of a premarket notification filed by Boston Surgical Products, Inc. with the FDA for Disposable & Resuable Irrigation/aspiration Handpiece.
| Device ID | K945171 |
| 510k Number | K945171 |
| Device Name: | DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | BOSTON SURGICAL PRODUCTS, INC. 203 INDIAN POND RD. Kingston, MA 02364 |
| Contact | Lawrence T Kirwan Jr |
| Correspondent | Lawrence T Kirwan Jr BOSTON SURGICAL PRODUCTS, INC. 203 INDIAN POND RD. Kingston, MA 02364 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-21 |
| Decision Date | 1995-02-08 |