ONEUSE- PLUS MICROKERATOME
FDA 510(k) clearance K040297 · decided 2004-03-31
Clearance details
- K-number
- K040297
- Device name
- ONEUSE- PLUS MICROKERATOME
- Applicant
- Moria SA
- Decision
- Substantially Equivalent
- Date received
- 2004-02-09
- Decision date
- 2004-03-31
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- HMY
- Device class
- 1
- Regulation number
- 886.4370
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Antony, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BD K-4000 MICROKERATOME SYSTEM (K023092) | Becton, Dickinson & CO | 2002-10-18 |
| BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME (K022637) | Becton, Dickinson & CO | 2002-10-16 |
| M2 SINGLE USE MICROKERTOME (K022560) | Moria SA | 2002-09-27 |
| CARRIAZO BARRAQUER SINGLE USE MICROKERATOME (K003594) | Moria, Inc. | 2001-03-09 |
| CARRIAZO BARRAQUER II MICROKERATOME (K002191) | Moria, Inc. | 2000-10-12 |
| MILLENIUM MICROKERATOME, MODEL IMD-001 (K992687) | Industrial & Medical Design, Inc. | 1999-09-24 |
| KERATOME SYSTEM, MODEL K3000 (K984537) | Insight Technologies Instruments, LLC | 1999-05-14 |
| CARRIAZO BARRAQUER MICROKERATOME (K981741) | Moria, Inc. | 1998-07-24 |
| KERATOME SYSTEM (K974243) | Insight Technologies Instruments, LLC | 1998-01-20 |
| VISI-DRAPE OPHTHALMIC DRAPES (K902857) | Visitec Co. | 1990-07-31 |
| OSCILLATING KNIFE AND ACCESSORIES (K781412) | Codman & Shurtleff, Inc. | 1978-10-11 |
Recalls involving this device
No recalls on record reference this clearance.