MENTOR GEMINI HEMOSTATIC ERASER
FDA 510(k) clearance K971538 · decided 1997-07-14
Clearance details
- K-number
- K971538
- Device name
- MENTOR GEMINI HEMOSTATIC ERASER
- Applicant
- Mentor Ophthalmics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-04-28
- Decision date
- 1997-07-14
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- HQO
- Device class
- 2
- Regulation number
- 886.4115
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Norwell, MA, US
- Third-party review
- No
- Expedited review
- No
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| EFFNER-EYE CAUTERY WITH BATTERY HANDLE (K844775) | Mecron Medical Products, Inc. | 1985-08-12 |
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Recalls involving this device
No recalls on record reference this clearance.