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510(k) K945269

OPTUS LARYNGOSCOPES by Optus, Inc. — Product Code CCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1994
Date Received
October 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Rigid
Device Class
Class I
Regulation Number
868.5540
Review Panel
AN
Submission Type

Other clearances by Optus, Inc.

  • K945264 — OPTUS OTOSCOPES (February 2, 1996)
  • K953913 — OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES (January 22, 1996)
  • K945268 — OPTUS BRONCHOSCOPES (December 21, 1995)
  • K945265 — OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES (September 12, 1995)
  • K945262 — OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES (May 26, 1995)
  • K945267 — OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES (May 23, 1995)
  • K945266 — OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES (February 23, 1995)
  • K944656 — OPTUS SINUSCOPES AND ACCESSORIES (January 26, 1995)
  • K945263 — OPTUS THORACOSCOPES (December 13, 1994)

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  • K062231 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 (August 31, 2006)
  • K041852 — MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 (November 15, 2004)
  • K984101 — FLEXIBLADE (September 3, 1999)