FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
InnoGenic Non-resorbable Membrane
K Number: K211554
·
Decision Feb 24, 2023
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
30
Applicant Total
14
Review Days
646
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Basic Information
- Device Name
- InnoGenic Non-resorbable Membrane
- K Number
- K211554
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cowellmedi Co., Ltd.
- Date Received
- May 19, 2021
- Decision Date
- February 24, 2023
- Product Code
- NPK
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| NPK | Barrier, Synthetic, Intraoral | FDA class 2 | Dental |
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