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510(k) K923843

FOGLESS by Sorex Medical — Product Code OCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1994
Date Received
July 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti Fog Solution And Accessories, Endoscopy
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

Other clearances by Sorex Medical

  • K913036 — PLUME MASTER (September 6, 1991)
  • K911070 — PICC-FIX (July 5, 1991)
  • K911150 — SOREX SAFE-AIR (June 28, 1991)
  • K910315 — PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K (April 5, 1991)
  • K905572 — EDLICH WOUND MANAGEMENT TRAY (March 12, 1991)
  • K903740 — TRACH-EZE (December 6, 1990)
  • K902410 — MEDICAL PROCEDURE TRAY (November 20, 1990)
  • K885136 — GRAFT GUARD (February 6, 1989)

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  • K120821 — LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM (May 11, 2012)
  • K111622 — UNIMAX ANTI-FOG SOLUTION (September 9, 2011)
  • K102452 — DEFOGGING AND CLEANING SOLUTION- FLO-X (December 23, 2010)