FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDROFIX SURGICAL SHEET
K Number: K100313
·
Decision Jun 14, 2011
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
5
Review Days
495
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Basic Information
- Device Name
- HYDROFIX SURGICAL SHEET
- K Number
- K100313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mimedx Group, Inc.
- Date Received
- February 4, 2010
- Decision Date
- June 14, 2011
- Product Code
- FTL
- 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | FDA class 2 | General, Plastic Surgery |
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