The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Site Simcoe Style I/a Handpiece.
Device ID | K842458 |
510k Number | K842458 |
Device Name: | SITE SIMCOE STYLE I/A HANDPIECE |
Classification | Unit, Phacofragmentation |
Applicant | CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-22 |
Decision Date | 1984-08-15 |