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510(k) K945265

OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES by Optus, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1995
Date Received
October 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
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)
  • 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)
  • K945269 — OPTUS LARYNGOSCOPES (November 7, 1994)

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