FDA 510(k)
FDA unclassified
Substantially Equivalent
🇯🇵 Japan
PELNAC Meshed Bilayer Wound Matrix
K Number: K213498
·
Decision Jul 14, 2022
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
5
Review Days
255
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Basic Information
- Device Name
- PELNAC Meshed Bilayer Wound Matrix
- K Number
- K213498
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gunze Limited
- Date Received
- November 1, 2021
- Decision Date
- July 14, 2022
- 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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