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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 K090584
Device Name INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
Applicant
CARL ZEISS SURGICAL GMBH
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Applicant Contact MARK W SHEEHAN
Correspondent
CARL ZEISS SURGICAL GMBH
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Correspondent Contact MARK W SHEEHAN
Regulation Number892.5900
Classification Product Code
JAD  
Date Received03/03/2009
Decision Date 11/24/2009
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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