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FDA 510(k) Application Details - K973864
Device Classification Name
System, X-Ray, Tomographic
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510(K) Number
K973864
Device Name
System, X-Ray, Tomographic
Applicant
PAUSCH CORP.
808 SHREWSBURY AVE.
TENTON FALLS, NJ 07724 US
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Contact
KENNETH J H. RICE
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Regulation Number
892.1740
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Classification Product Code
IZF
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More FDA Info for this Product Code
Date Received
10/09/1997
Decision Date
06/17/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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