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510(k) K896707

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

K896707 is an FDA 510(k) premarket notification submitted by Perlink USA, Inc. for the device "PERLINK SCREEN, KIRAN SCREEN". The FDA issued a decision of Substantially Equivalent on August 30, 1990. The device falls under product code EAM (Screen, Intensifying, Radiographic), a Class I device regulated under 21 CFR 892.1960. Perlink USA, Inc. has at least 5 other 510(k) clearances on record.

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

  • K974423 — ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL (December 22, 1997)
  • K963913 — MD100 & MM150 (October 8, 1997)
  • K954161 — JPI INTENSIFYING SCREEN (February 2, 1996)
  • K943821 — KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC (August 22, 1994)
  • K943822 — FUJI UM MAMMO SERIES INTENSIFY SCREENS: (August 22, 1994)
  • K943823 — FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 (August 22, 1994)
  • K942235 — KYOKKO GREEN SERIES INTENSIFYING SCREENS (August 17, 1994)
  • K943425 — FUJI HG-M INTENSIFYING SCREEN (August 17, 1994)
  • K942909 — KODAK INSIGHT TWIN-LOAD INSERT (July 29, 1994)
  • K942805 — KYOKKO BLUE SERIES INTENSIFYING SCREENS (July 29, 1994)

FDA data resources