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510(k) K002146

KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY by Eastman Kodak Company — Product Code LMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2000
Date Received
July 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
Review Panel
RA
Submission Type

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