FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRODYNE OFFICE SURGICAL MICROSCOPE
K Number: K931284
·
Decision Nov 18, 1993
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
17
Applicant Total
1
Review Days
280
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Basic Information
- Device Name
- MICRODYNE OFFICE SURGICAL MICROSCOPE
- K Number
- K931284
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4700
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Microdyne, Inc.
- Date Received
- February 11, 1993
- Decision Date
- November 18, 1993
- Product Code
- EPT
- 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 |
|---|---|---|---|
| EPT | Microscope, Surgical | FDA class 1 | General, Plastic Surgery |
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