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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 K141830
Device Name STIMULAN KIT, STIMULAN RAPID CURE
Applicant
BIOCOMPOSITES LTD.
KEELE SCIENCE PARK
KEELE, STAFFORDSHIRE,  GB ST5 5NL
Applicant Contact MARIE WHALLEY
Correspondent
BIOCOMPOSITES LTD.
KEELE SCIENCE PARK
KEELE, STAFFORDSHIRE,  GB ST5 5NL
Correspondent Contact SIMON FITZER
Regulation Number888.3045
Classification Product Code
MQV  
Date Received07/07/2014
Decision Date 01/23/2015
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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