BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE
FDA 510(k) clearance K050446 · decided 2005-08-09
Clearance details
- K-number
- K050446
- Device name
- BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE
- Applicant
- Ed. Geistlich Soehne AG Fuer Chemische Industrie
- Decision
- Substantially Equivalent
- Date received
- 2005-02-22
- Decision date
- 2005-08-09
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- NPL
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.