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FDA 510(k) Application Details - K013686
Device Classification Name
Cassette, Radiographic Film
More FDA Info for this Device
510(K) Number
K013686
Device Name
Cassette, Radiographic Film
Applicant
EASTMAN KODAK COMPANY
1669 LAKE AVE.
ROCHESTER, NY 14652 US
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Contact
JUDITH A WALLACE
Other 510(k) Applications for this Contact
Regulation Number
892.1850
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Classification Product Code
IXA
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More FDA Info for this Product Code
Date Received
11/07/2001
Decision Date
12/07/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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