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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, therapeutic, x-ray
510(k) Number K051055
Device Name INTRABEAM SYSTEM
Applicant
CARL ZEISS SURGICAL GMBH
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
CARL ZEISS SURGICAL GMBH
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number892.5900
Classification Product Code
JAD  
Date Received04/26/2005
Decision Date 05/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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