The following data is part of a premarket notification filed by Moria, Inc. with the FDA for Carriazo Barraquer Single Use Microkeratome.
Device ID | K003594 |
510k Number | K003594 |
Device Name: | CARRIAZO BARRAQUER SINGLE USE MICROKERATOME |
Classification | Keratome, Battery-powered |
Applicant | MORIA, INC. 15 RUE GEORGES BESSE Antony, FR 92160 |
Contact | David Conrad |
Correspondent | David Conrad MORIA, INC. 15 RUE GEORGES BESSE Antony, FR 92160 |
Product Code | HMY |
CFR Regulation Number | 886.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-11-21 |
Decision Date | 2001-03-09 |