The following data is part of a premarket notification filed by Microsurgical Technology, Inc. with the FDA for The New Mcintyre Cannula.
| Device ID | K853777 |
| 510k Number | K853777 |
| Device Name: | THE NEW MCINTYRE CANNULA |
| Classification | Cannula, Ophthalmic |
| Applicant | MICROSURGICAL TECHNOLOGY, INC. 723 B 9TH AVE. Kirkland, WA 98033 |
| Contact | Nelsson |
| Correspondent | Nelsson 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 | 1985-09-09 |
| Decision Date | 1985-11-21 |