FDA 510(k)
FDA class 1
Substantially Equivalent
🇸🇪 Sweden
COOL CUT
K Number: K931429
·
Decision Apr 29, 1994
Classifications
1
FEI Numbers
387
Registration Numbers
387
Same Product Code
75
Applicant Total
1
Review Days
403
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Basic Information
- Device Name
- COOL CUT
- K Number
- K931429
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mitab
- Date Received
- March 22, 1993
- Decision Date
- April 29, 1994
- Product Code
- HWE
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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