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FDA 510(k) Application Details - K955411
Device Classification Name
System, X-Ray, Mammographic
More FDA Info for this Device
510(K) Number
K955411
Device Name
System, X-Ray, Mammographic
Applicant
INSTRUMENTARIUM IMAGING, INC.
P.O. BOX 20 (NAHKELANTIE 160)
FIN-04301
TUUSULA, FINLAND FI
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Contact
RISTO MYNTTINEN
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
11/27/1995
Decision Date
03/21/1996
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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