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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessory, barium sulfate, methyl methacrylate for cranioplasty
510(k) Number K002063
Device Name BIOTRACE, MODEL 1730
Applicant
BRYAN CORP.
FOUR PLYMPTON ST.
WOBURN,  MA  01801
Applicant Contact ROSE S LOGSDON
Correspondent
BRYAN CORP.
FOUR PLYMPTON ST.
WOBURN,  MA  01801
Correspondent Contact ROSE S LOGSDON
Regulation Number882.5300
Classification Product Code
MYU  
Date Received07/07/2000
Decision Date 08/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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