FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MENTOR GEMINI HEMOSTATIC ERASER
K Number: K971538
·
Decision Jul 14, 1997
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
11
Applicant Total
4
Review Days
77
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Basic Information
- Device Name
- MENTOR GEMINI HEMOSTATIC ERASER
- K Number
- K971538
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4115
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mentor Ophthalmics, Inc.
- Date Received
- April 28, 1997
- Decision Date
- July 14, 1997
- Product Code
- HQO
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HQO | Unit, Cautery, Thermal, Ac-Powered | FDA class 2 | Ophthalmic |
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