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510(k) K051979

ORS MODEL 6000 ENDOSCOPE HOLDER by O.R. Solutions, Inc. — Product Code OCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2005
Date Received
July 21, 2005
Clearance Type
Special
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 O.R. Solutions, Inc.

  • K023283 — 1075LD HUSH-SLUSH (November 13, 2002)
  • K023282 — ORS-3000LD (November 13, 2002)
  • K021288 — ORS-1000LD (June 27, 2002)
  • K021289 — WARMER 2000LD (June 26, 2002)
  • K960836 — DMS-9000 (September 12, 1996)
  • K953654 — ORS-111 (September 22, 1995)

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  • K190864 — Konix Anti-Fog Solution (August 27, 2020)
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  • K152948 — Medline Anti-Fog Solution (February 4, 2016)
  • 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)