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510(k) K901014

RADIOGRAPHIC INTENSIFYING SCREEN by Infab Corp. — Product Code EAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1990
Date Received
March 5, 1990
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

Other clearances by Infab Corp.

  • K900970 — RADIATION PROTECTION GLASSES (May 1, 1990)
  • K900972 — RADIATION PROTECTION GLOVES (May 1, 1990)
  • K901012 — RADIOGRAPHIC GRID (March 28, 1990)
  • K901013 — RADIOGRAPHIC FILM CASSETTE (March 28, 1990)
  • K896289 — RADIATION PROTECTION APRON (December 14, 1989)

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  • K943822 — FUJI UM MAMMO SERIES INTENSIFY SCREENS: (August 22, 1994)
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  • K942909 — KODAK INSIGHT TWIN-LOAD INSERT (July 29, 1994)
  • K942805 — KYOKKO BLUE SERIES INTENSIFYING SCREENS (July 29, 1994)