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510(k) K921942

HYSTEROSCOPE (AND ACCESSORIES) by Optimed Technologies, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1994
Date Received
April 24, 1992
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 Optimed Technologies, Inc.

  • K972520 — OPTIVIEW (September 29, 1997)
  • K955274 — BOOSTER LITE 3 MOTORIZED SCOOTER (November 4, 1996)
  • K955275 — BOOSTER TROPHY 5 MOTORIZED SCOOTER (November 4, 1996)
  • K955276 — BOOSTER LITE 4 MOTORIZED SCOOTER (November 4, 1996)
  • K943598 — FLEXIBLE FIBER OPTIC LAPAROSCOPES (October 18, 1994)
  • K926597 — LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) (July 12, 1994)
  • K922711 — FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE (May 17, 1994)
  • K921985 — ARTHROSCOPE & ACCESSORIES (June 29, 1993)
  • K922826 — FLEXIBLE FIBER OPTIC ENDOSCOPE (February 19, 1993)
  • K921883 — ENDOSCOPE (November 23, 1992)

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