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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K101398
Device Name STEREOS WORKSTATION
Applicant
BIOSPACE MED
555 THIRTEENTH ST. NW
WASHINGTON,  DC  20004
Applicant Contact JOHN J SMITH
Correspondent
BIOSPACE MED
555 THIRTEENTH ST. NW
WASHINGTON,  DC  20004
Correspondent Contact JOHN J SMITH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/18/2010
Decision Date 02/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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