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FDA 510(k) Application Details - K051055
Device Classification Name
System, Therapeutic, X-Ray
More FDA Info for this Device
510(K) Number
K051055
Device Name
System, Therapeutic, X-Ray
Applicant
CARL ZEISS SURGICAL GMBH
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact
ROSINA ROBINSON
Other 510(k) Applications for this Contact
Regulation Number
892.5900
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Classification Product Code
JAD
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More FDA Info for this Product Code
Date Received
04/26/2005
Decision Date
05/23/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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