FLAPMAKER DISPOSABLE MICROKERATOME
FDA 510(k) clearance K981155 · decided 1998-08-14
Clearance details
- K-number
- K981155
- Device name
- FLAPMAKER DISPOSABLE MICROKERATOME
- Applicant
- Hawken Industries
- Decision
- Substantially Equivalent
- Date received
- 1998-03-31
- Decision date
- 1998-08-14
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- HNO
- Device class
- 1
- Regulation number
- 886.4370
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| ZYOPTIX XP EPI SEPARATOR SYSTEM (K062465) | Bausch & Lomb, Inc. | 2006-09-06 |
| HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM (K052891) | Hawken Industries | 2006-03-23 |
| NORWOOD ABBEY CENTURION SES EPIKERATOME (K051486) | Norwood Abbey , Ltd. | 2005-07-06 |
| EPI-K (K043183) | Moria SA | 2005-03-25 |
| AMADEUS II EPIKERATOME (K043150) | Sis Ltd., Surgical Instrument Systems | 2005-01-31 |
| MODIFICATION TO VISITOME 20-10 MICROKERATOME (K042083) | Biovision AG | 2004-11-16 |
| CENTURION SES EPIKERATOME (K042810) | Norwood Abbey , Ltd. | 2004-10-28 |
| MB 105 MILLENNIUM BLADES (K041110) | Millennium Biomedical, Inc. | 2004-10-13 |
Recalls involving this device
No recalls on record reference this clearance.