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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 K121653
Device Name INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS
Applicant
CARL ZEISS MEDITEC, INC.
5160 HACIENDA DRIVE
DUBLIN,  CA  95030
Applicant Contact SARAH HARRINGTON
Correspondent
CARL ZEISS MEDITEC, INC.
5160 HACIENDA DRIVE
DUBLIN,  CA  95030
Correspondent Contact SARAH HARRINGTON
Regulation Number892.5900
Classification Product Code
JAD  
Date Received06/05/2012
Decision Date 12/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Clinical Trials NCT00983684
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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