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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K152077
Device Name MaxiGen
Applicant
Hans Biomed Corp.
64, Yuseong-Daero 1628 Beon-Gil, Yuseong-Gu
Daejeon,  KR 305-811
Applicant Contact LUCY CHOI
Correspondent
Trisler Consulting
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Correspondent Contact PATSY J TRISLER
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received07/27/2015
Decision Date 04/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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