The following data is part of a premarket notification filed by Moria, Inc. with the FDA for Carriazo Barraquer Ii Microkeratome.
| Device ID | K002191 |
| 510k Number | K002191 |
| Device Name: | CARRIAZO BARRAQUER II 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 | 2000-07-20 |
| Decision Date | 2000-10-12 |