The following data is part of a premarket notification filed by Microsurgical Technology, Inc. with the FDA for Phaco Needles And Tips.
Device ID | K943672 |
510k Number | K943672 |
Device Name: | PHACO NEEDLES AND TIPS |
Classification | Unit, Phacofragmentation |
Applicant | MICROSURGICAL TECHNOLOGY, INC. 723-B 9TH AVE. Kirkland, WA 98033 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-26 |
Decision Date | 1994-10-13 |