TEFGEN GUIDED TISSUE MEMBRANE— 510(k) K964656
Substantially EquivalentAmerican Custom Medical, Inc.
FDA 510(k) clearance K964656 for TEFGEN GUIDED TISSUE MEMBRANE, Substantially Equivalent on 1997-02-10. Applicant: American Custom Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- American Custom Medical, Inc.
- Product code
- Code NPK
- Device class
- Class 2
- Regulation
- 21 CFR 872.3930
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bozeman, MT, US
Recent devices under product code NPK
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