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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, cutting, orthopedic
510(k) Number K931737
Device Name HEDLEYL INTRAMEDULLARY PREPARATION BRUSH
Applicant
SYNVASIVE TECHNOLOGY, INC.
11328 SUNRISE GOLD CIRCLE
RANCHO CORDOVA,  CA  95742
Applicant Contact CAROL LAUFENBERG
Correspondent
SYNVASIVE TECHNOLOGY, INC.
11328 SUNRISE GOLD CIRCLE
RANCHO CORDOVA,  CA  95742
Correspondent Contact CAROL LAUFENBERG
Regulation Number878.4800
Classification Product Code
HTZ  
Date Received04/07/1993
Decision Date 01/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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