FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
PRIMATRIX DERMAL REPAIR SCAFFOLD
K Number: K083440
·
Decision Dec 12, 2008
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
16
Review Days
22
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Basic Information
- Device Name
- PRIMATRIX DERMAL REPAIR SCAFFOLD
- K Number
- K083440
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tei Biosciences, Inc.
- Date Received
- November 20, 2008
- Decision Date
- December 12, 2008
- 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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|---|---|---|---|
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| K131286 | PRIMATRIX DERMAL REPAIR SCAFFOLD | Aug 5, 2013 | Substantially Equivalent |
| K100261 | PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD | Dec 10, 2010 | Substantially Equivalent |
| K083898 | SURGIMEND | Feb 4, 2009 | Substantially Equivalent |
| K071807 | ORTHOMEND SOFT TISSUE MATRIX | Aug 6, 2007 | Substantially Equivalent |
| K061407 | PRIMATRIX DERMAL REPAIR SCAFFOLD | Jun 29, 2006 | Substantially Equivalent |
| K060829 | COSMATRIX | May 17, 2006 | Substantially Equivalent |
| K060984 | XENFORM SOFT TISSUE REPAIR MATRIX | May 17, 2006 | Substantially Equivalent |
| K060989 | TISSUEMEND SOFT TISSUE REPAIR MATRIX | May 15, 2006 | Substantially Equivalent |