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510(k) K003840

CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES by I.C Medical, Inc. — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2001
Date Received
December 12, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

Other clearances by I.C Medical, Inc.

  • K163659 — Crystal Vision (October 30, 2017)
  • K160160 — Non-Telescopic PenEvac (April 5, 2016)
  • K960492 — SI CONTROLLER MODEL SI 500 (December 23, 1996)
  • K961616 — TELESCOPING PENEVAC (MODIFICATION) (May 28, 1996)
  • K955166 — PENEVAC SI. (April 11, 1996)
  • K955020 — PENEVAC ABC HANDPIECE (April 9, 1996)
  • K953418 — ELECTROCAUTERY SHROUD (October 7, 1995)
  • K954088 — TELESCOPING PENEVAC (September 22, 1995)
  • K932230 — CRYSTAL VISION AND ACCESSORIES (February 18, 1994)
  • K930097 — ELECTROCAUTERY SHROUD (July 28, 1993)

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  • K182224 — SafeAir Smoke Evacuator compact (February 7, 2019)
  • K173108 — Smoklean (May 18, 2018)
  • K163659 — Crystal Vision (October 30, 2017)