FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES
K Number: K123908
·
Decision Jul 31, 2013
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
24
Applicant Total
1
Review Days
224
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Basic Information
- Device Name
- OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES
- K Number
- K123908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3500
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Matrix Surgical USA
- Date Received
- December 19, 2012
- Decision Date
- July 31, 2013
- Product Code
- KKY
- 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 |
|---|---|---|---|
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | FDA class 2 | General, Plastic Surgery |
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