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FDA 510(k) Application Details - K121653
Device Classification Name
System, Therapeutic, X-Ray
More FDA Info for this Device
510(K) Number
K121653
Device Name
System, Therapeutic, X-Ray
Applicant
CARL ZEISS MEDITEC, INC.
5160 HACIENDA DRIVE
DUBLIN, CA 95030 US
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Contact
SARAH HARRINGTON
Other 510(k) Applications for this Contact
Regulation Number
892.5900
More FDA Info for this Regulation Number
Classification Product Code
JAD
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More FDA Info for this Product Code
Date Received
06/05/2012
Decision Date
12/27/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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