SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY— 510(k) K113728

Name: FDA 510(k) clearance K113728
Creator: U.S. Food and Drug Administration
Published: 2012-11-15

Substantially Equivalent

Hans Biomed Corp.

FDA 510(k) clearance K113728 for SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY, Substantially Equivalent on 2012-11-15. Applicant: Hans Biomed Corp.. Device class: 2.

Clearance details

Applicant: Hans Biomed Corp.
Product code: Code MBP
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2011-12-19
Decision date: 2012-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chevy Chase, MD, US

Download summary PDF View on FDA.gov ↗

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