The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Dicon Glaucoma Diag. Center 2000 Series.
Device ID | K832142 |
510k Number | K832142 |
Device Name: | DICON GLAUCOMA DIAG. CENTER 2000 SERIES |
Classification | Perimeter, Automatic, Ac-powered |
Applicant | COOPERVISION, INC. PERMALENS HOUSE 1 BOTLEY ROAD, HEDGE END Southampton, GB S033hb |
Product Code | HPT |
CFR Regulation Number | 886.1605 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-05 |
Decision Date | 1983-08-01 |