FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm
K Number: K160493
·
Decision Sep 8, 2016
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
30
Applicant Total
2
Review Days
199
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Basic Information
- Device Name
- Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm
- K Number
- K160493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Salvin Dental Specialties
- Date Received
- February 22, 2016
- Decision Date
- September 8, 2016
- 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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Other Clearances by Salvin Dental Specialties
| K Number | Device Name | ||
|---|---|---|---|
| K161857 | Salvin Tenting Screw System | Apr 28, 2017 | Substantially Equivalent |