The following data is part of a premarket notification filed by Cci with the FDA for Cci Videokeratoscope/comparator.
Device ID | K913022 |
510k Number | K913022 |
Device Name: | CCI VIDEOKERATOSCOPE/COMPARATOR |
Classification | Keratoscope, Ac-powered |
Applicant | CCI 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
Contact | Charles L.rose |
Correspondent | Charles L.rose CCI 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
Product Code | HLQ |
CFR Regulation Number | 886.1350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-09 |
Decision Date | 1991-10-09 |