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510(k) K896707

PERLINK SCREEN, KIRAN SCREEN by Perlink USA, Inc. — Product Code EAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1990
Date Received
November 28, 1989
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 Perlink USA, Inc.

  • K922358 — STERLING POWDER FREE PATIENT EXAMINATION GLOVES (June 11, 1993)
  • K924959 — STERLING LATEX EXAM GLOVE, HYPO-ALLERGENIC (March 3, 1993)
  • K921438 — DISPOSABLE LATEX EXAMINATION GLOVES (June 23, 1992)
  • K901790 — THERMOMETER, MERCURY/CLINICAL (July 11, 1990)
  • K896708 — PERLINK CASSETTE, KIRAN CASSETTE (May 7, 1990)

Other clearances for product code EAM

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  • K963913 — MD100 & MM150 (October 8, 1997)
  • K954161 — JPI INTENSIFYING SCREEN (February 2, 1996)
  • K943823 — FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 (August 22, 1994)
  • K943821 — KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC (August 22, 1994)
  • 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)
  • K942909 — KODAK INSIGHT TWIN-LOAD INSERT (July 29, 1994)
  • K942805 — KYOKKO BLUE SERIES INTENSIFYING SCREENS (July 29, 1994)