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510(k) K901013

RADIOGRAPHIC FILM CASSETTE by Infab Corp. — Product Code IXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1990
Date Received
March 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassette, Radiographic Film
Device Class
Class II
Regulation Number
892.1850
Review Panel
RA
Submission Type

Other clearances by Infab Corp.

  • K900970 — RADIATION PROTECTION GLASSES (May 1, 1990)
  • K900972 — RADIATION PROTECTION GLOVES (May 1, 1990)
  • K901014 — RADIOGRAPHIC INTENSIFYING SCREEN (April 2, 1990)
  • K901012 — RADIOGRAPHIC GRID (March 28, 1990)
  • K896289 — RADIATION PROTECTION APRON (December 14, 1989)

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  • K983918 — RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) (March 12, 1999)
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