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FDA 510(k), K130235, SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
FDA 510(k), K130235, SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
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510(K) Number: K130235
Device Name: SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
Manufacturer: HANS BIOMED CORP.
Device Classification Name: bone grafting material, human source
Regulation Number: 872.3930
Classification Product Code: NUN
Date Received: 01/30/2013
Decision Date: 01/10/2014
Regulation Medical Specialty: Dental
Device Name: SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
Manufacturer: HANS BIOMED CORP.
Device Classification Name: bone grafting material, human source
Regulation Number: 872.3930
Classification Product Code: NUN
Date Received: 01/30/2013
Decision Date: 01/10/2014
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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