FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MOLLER-WEDEL OPERATING MICROSCOPE
K Number: K926513
·
Decision Jun 22, 1993
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
14
Applicant Total
2
Review Days
174
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Basic Information
- Device Name
- MOLLER-WEDEL OPERATING MICROSCOPE
- K Number
- K926513
- 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
- Moeller Microsurgical, Inc.
- Date Received
- December 30, 1992
- Decision Date
- June 22, 1993
- Product Code
- FSO
- 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 |
|---|---|---|---|
| FSO | Microscope, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSO), ordered by most recent decision date.
MICROFLEX
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DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM
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SOM 6VI (SURGICAL OPERATING MICROSCOPE)
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WOODLYN OPERATION MICROSCOPE
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SOM 6V
FDA 510(k)
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Other Clearances by Moeller Microsurgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942304 | MICROFLEX | Jun 13, 1994 | Substantially Equivalent |