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510(k) K896708

PERLINK CASSETTE, KIRAN CASSETTE by Perlink USA, Inc. — Product Code IXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1990
Date Received
November 28, 1989
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 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)
  • K896707 — PERLINK SCREEN, KIRAN SCREEN (August 30, 1990)
  • K901790 — THERMOMETER, MERCURY/CLINICAL (July 11, 1990)

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  • K983918 — RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) (March 12, 1999)
  • K980722 — TRIMAX RADIOGRAPHIC CASSETTE (March 23, 1998)