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FDA 510(k) Application Details - K973493
Device Classification Name
System, X-Ray, Mammographic
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510(K) Number
K973493
Device Name
System, X-Ray, Mammographic
Applicant
PLANMED OY
362, BALM COURT
WOOD DALE, IL 60191 US
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Contact
BOB PIENKOWSKI
Other 510(k) Applications for this Contact
Regulation Number
892.1710
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Classification Product Code
IZH
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More FDA Info for this Product Code
Date Received
09/15/1997
Decision Date
11/10/1997
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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