The following data is part of a premarket notification filed by Microsurgical Technology, Inc. with the FDA for The New Mcintyre I.a. Handpiece.
| Device ID | K854402 |
| 510k Number | K854402 |
| Device Name: | THE NEW MCINTYRE I.A. HANDPIECE |
| Classification | Cannula, Ophthalmic |
| Applicant | MICROSURGICAL TECHNOLOGY, INC. 723 B 9TH AVE. Kirkland, WA 98033 |
| Contact | Nilsson |
| Correspondent | Nilsson MICROSURGICAL TECHNOLOGY, INC. 723 B 9TH AVE. Kirkland, WA 98033 |
| Product Code | HMX |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-31 |
| Decision Date | 1985-12-30 |