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FDA 510(k) Application Details - K071378
Device Classification Name
System, X-Ray, Tomography, Computed
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510(K) Number
K071378
Device Name
System, X-Ray, Tomography, Computed
Applicant
E-Z-EM, INC.
750 SUMMA AVE.
WESTBURY, NY 11590 US
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Contact
STEVEN HARTMAN
Other 510(k) Applications for this Contact
Regulation Number
892.1750
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Classification Product Code
JAK
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More FDA Info for this Product Code
Date Received
05/17/2007
Decision Date
06/13/2007
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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