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510(k) K942909

KODAK INSIGHT TWIN-LOAD INSERT by Eastman Kodak Company — Product Code EAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1994
Date Received
June 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screen, Intensifying, Radiographic
Device Class
Class I
Regulation Number
892.1960
Review Panel
RA
Submission Type

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  • K943822 — FUJI UM MAMMO SERIES INTENSIFY SCREENS: (August 22, 1994)
  • K943425 — FUJI HG-M INTENSIFYING SCREEN (August 17, 1994)
  • K942235 — KYOKKO GREEN SERIES INTENSIFYING SCREENS (August 17, 1994)
  • K942805 — KYOKKO BLUE SERIES INTENSIFYING SCREENS (July 29, 1994)
  • K942399 — KYOKKO UM SERIES INTENSIFYING SCREEN (June 10, 1994)