FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
UNITE BIOMATRIX
K Number: K112399
·
Decision Sep 7, 2011
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
3
Review Days
19
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Basic Information
- Device Name
- UNITE BIOMATRIX
- K Number
- K112399
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synovis Orthopedic & Woundcare
- Date Received
- August 19, 2011
- Decision Date
- September 7, 2011
- Product Code
- KGN
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
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