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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 K003954
Device Name STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
Applicant
Biocomposites, Ltd.
Etruscan St., Etruria
Stoke On Trent,  GB ST1 5PQ
Applicant Contact J. STEPHEN BRATT
Correspondent
Biocomposites, Ltd.
Etruscan St., Etruria
Stoke On Trent,  GB ST1 5PQ
Correspondent Contact J. STEPHEN BRATT
Regulation Number888.3045
Classification Product Code
MQV  
Date Received12/21/2000
Decision Date 07/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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