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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, aspiration and injection, reusable
510(k) Number K071732
Device Name MARROWMINER
Applicant
STEMCOR SYSTEMS, INC.
5582 CHALON ROAD
YORBA LINDA,  CA  92886
Applicant Contact SHARON ROCKWELL
Correspondent
STEMCOR SYSTEMS, INC.
5582 CHALON ROAD
YORBA LINDA,  CA  92886
Correspondent Contact SHARON ROCKWELL
Regulation Number878.4800
Classification Product Code
GDM  
Subsequent Product Code
GAA  
Date Received06/26/2007
Decision Date 09/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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