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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 K132071
FOIA Releasable 510(k) K132071
Device Name BIOACTIVE BONE GRAFT PUTTY
Applicant
BIOSTRUCTURES, LLC
5600 WISCONSIN AVE. #509
CHEVY CHASE,  MD  20815
Applicant Contact PATSY J TRISLER, JD, RAC
Correspondent
BIOSTRUCTURES, LLC
5600 WISCONSIN AVE. #509
CHEVY CHASE,  MD  20815
Correspondent Contact PATSY J TRISLER, JD, RAC
Regulation Number888.3045
Classification Product Code
MQV  
Date Received07/03/2013
Decision Date 01/10/2014
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
Recalls CDRH Recalls
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