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510(k) K974801

SINGLE CHANNEL BALLOON CANNULA by Conkin Surgical Instruments , Ltd. — Product Code HDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1998
Date Received
December 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elevator, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances for product code HDP

  • K974563 — COLPO CUP CVC-2000 (March 2, 1998)
  • K882054 — HYSTERO KIT (September 29, 1988)
  • K820672 — HASSON BUEC-3 (July 30, 1982)