FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
NovoGen Wound Matrix
K Number: K220498
·
Decision Jun 9, 2023
Classifications
1
FEI Numbers
122
Registration Numbers
122
Same Product Code
155
Applicant Total
1
Review Days
472
Basic Information
- Device Name
- NovoGen Wound Matrix
- K Number
- K220498
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Novabone Products, LLC
- Date Received
- February 22, 2022
- Decision Date
- June 9, 2023
- 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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