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FDA 510(k) Application Details - K973710
Device Classification Name
System, X-Ray, Stationary
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510(K) Number
K973710
Device Name
System, X-Ray, Stationary
Applicant
SWISSRAY INTERNATIONAL, INC.
121 METRO POLITAN DR.
LIVERPOOL, NY 13088 US
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Contact
MORTEZA MINAEE
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Regulation Number
892.1680
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Classification Product Code
KPR
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More FDA Info for this Product Code
Date Received
09/29/1997
Decision Date
12/18/1997
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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