FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EXICLIP EXCS-M
K Number: K070836
·
Decision Apr 20, 2007
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
6
Applicant Total
1
Review Days
24
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Basic Information
- Device Name
- EXICLIP EXCS-M
- K Number
- K070836
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clevex, Inc.
- Date Received
- March 27, 2007
- Decision Date
- April 20, 2007
- Product Code
- MJG
- 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 |
|---|---|---|---|
| MJG | Device, Percutaneous, Biopsy | FDA class 1 | General, Plastic Surgery |
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