FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
PRINEO SKIN CLOSURE SYSTEM
K Number: DEN090005
·
Decision Apr 30, 2010
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
8
Applicant Total
4
Review Days
402
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Basic Information
- Device Name
- PRINEO SKIN CLOSURE SYSTEM
- K Number
- DEN090005
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 878.4011
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Closure Medical Corp.
- Date Received
- March 24, 2009
- Decision Date
- April 30, 2010
- Product Code
- OMD
- 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 |
|---|---|---|---|
| OMD | Cutaneous Tissue Adhesive With Mesh | FDA class 2 | General, Plastic Surgery |
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