FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50
K Number: K854440
·
Decision Dec 16, 1985
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
13
Applicant Total
60
Review Days
41
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Basic Information
- Device Name
- MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50
- K Number
- K854440
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4700
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Keeler Instruments, Inc.
- Date Received
- November 5, 1985
- Decision Date
- December 16, 1985
- Product Code
- HRM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | FDA class 1 | General, Plastic Surgery |
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