SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY— 510(k) K130235

Name: FDA 510(k) clearance K130235
Creator: U.S. Food and Drug Administration
Published: 2014-01-10

Substantially Equivalent

Hans Biomed Corp.

FDA 510(k) clearance K130235 for SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY, Substantially Equivalent on 2014-01-10. Applicant: Hans Biomed Corp.. Device class: 2.

Clearance details

Applicant: Hans Biomed Corp.
Product code: Code NUN
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2013-01-30
Decision date: 2014-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chevy Chase, MD, US

Download summary PDF View on FDA.gov ↗

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