The following data is part of a premarket notification filed by Euclid Systems Corp. with the FDA for Euclid Systems Corneal Topographer Model Et800.
Device ID | K964702 |
510k Number | K964702 |
Device Name: | EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 |
Classification | Topographer, Corneal, Ac-powered |
Applicant | EUCLID SYSTEMS CORP. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
Contact | Anne Marie Cesario, R.a.c. |
Correspondent | Anne Marie Cesario, R.a.c. EUCLID SYSTEMS CORP. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
Product Code | MMQ |
CFR Regulation Number | 886.1350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-25 |
Decision Date | 1997-05-20 |