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FDA 510(k) Application Details - K973148
Device Classification Name
System, Image Processing, Radiological
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510(K) Number
K973148
Device Name
System, Image Processing, Radiological
Applicant
A. STEIN - REGULATORY AFFAIRS CONSULTING
P.O.B. 454
GINOT SHOMRON 44853 IL
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Contact
AHAVA STEIN
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Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
08/22/1997
Decision Date
11/20/1997
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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