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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 K092541
Device Name INTERFACE
Applicant
BIOSTRUCTURES
26552 TAMPICO PLACE
MISSION VIEJO,  CA  92691
Applicant Contact DAVE BALDING
Correspondent
BIOSTRUCTURES
26552 TAMPICO PLACE
MISSION VIEJO,  CA  92691
Correspondent Contact DAVE BALDING
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/19/2009
Decision Date 11/09/2010
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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