The following data is part of a premarket notification filed by Eclipse Ventures with the FDA for Corneal Topographer 200.
Device ID | K963762 |
510k Number | K963762 |
Device Name: | CORNEAL TOPOGRAPHER 200 |
Classification | Topographer, Corneal, Ac-powered |
Applicant | ECLIPSE VENTURES 108 SAYRE DR. Princeton, NJ 08540 |
Contact | Richard G Hunter |
Correspondent | Richard G Hunter ECLIPSE VENTURES 108 SAYRE DR. Princeton, NJ 08540 |
Product Code | MMQ |
CFR Regulation Number | 886.1350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-19 |
Decision Date | 1996-12-23 |