FDA 510(k) Application Details - K965096

Device Classification Name Table, Radiographic, Tilting

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510(K) Number K965096
Device Name Table, Radiographic, Tilting
Applicant U.S. IMAGING TABLES, INC.
28 CENTRAL AVE.
HAPPAUGE, NY 11788 US
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Contact ROBALD DENEZZO
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Regulation Number 892.1980

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Classification Product Code IXR
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Date Received 12/20/1996
Decision Date 01/27/1997
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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