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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, piston
510(k) Number K051720
Device Name SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
Applicant
SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Applicant Contact KATHY ANDERSON
Correspondent
SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Correspondent Contact KATHY ANDERSON
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/27/2005
Decision Date 07/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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