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FDA 510(k) Application Details - K053173
Device Classification Name
Cassette, Radiographic Film
More FDA Info for this Device
510(K) Number
K053173
Device Name
Cassette, Radiographic Film
Applicant
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
319 AKENO, OBATA-CHO
WATARAI-GUN
MIE-KEN 519-05 JP
Other 510(k) Applications for this Company
Contact
SHINICHI YAMANAKA
Other 510(k) Applications for this Contact
Regulation Number
892.1850
More FDA Info for this Regulation Number
Classification Product Code
IXA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/14/2005
Decision Date
12/15/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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