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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, osteoinduction (w/o human growth factor)
510(k) Number K061131
Device Name DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY
Applicant
ORTHOCON, INC.
167 STONE HILL ROAD
COLTS NECK,  NJ  07722
Applicant Contact Howard Schrayer
Correspondent
ORTHOCON, INC.
167 STONE HILL ROAD
COLTS NECK,  NJ  07722
Correspondent Contact Howard Schrayer
Regulation Number888.3045
Classification Product Code
MBP  
Subsequent Product Code
MTJ  
Date Received04/24/2006
Decision Date 02/08/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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