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510(k) K163659

Crystal Vision by I.C Medical, Inc. — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2017
Date Received
December 27, 2016
Clearance Type
Special
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.

  • K160160 — Non-Telescopic PenEvac (April 5, 2016)
  • K003840 — CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES (February 1, 2001)
  • 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)
  • K930098 — SPECULUM SMOKE EVACUATOR TUBING (July 28, 1993)

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