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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Human Source
510(k) Number K130235
Device Name SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
Applicant
Hans Biomed Corp.
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Applicant Contact PATSY J TRISLER, JD, RAC
Correspondent
Hans Biomed Corp.
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Correspondent Contact PATSY J TRISLER, JD, RAC
Regulation Number872.3930
Classification Product Code
NUN  
Date Received01/30/2013
Decision Date 01/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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