FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CUTO(TM) TISSUE MORCELLATION SYSTEM
K Number: K932700
·
Decision Oct 15, 1993
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
40
Applicant Total
93
Review Days
134
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Basic Information
- Device Name
- CUTO(TM) TISSUE MORCELLATION SYSTEM
- K Number
- K932700
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Linvatec Corp.
- Date Received
- June 3, 1993
- Decision Date
- October 15, 1993
- Product Code
- GEY
- 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 |
|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | FDA class 1 | General, Plastic Surgery |
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