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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
Recalls CDRH Recalls
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