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510(k) K220969

GelPOINT V-Path Vaginal Access System by Applied Medical Resources Corporation — Product Code MOK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2022
Date Received
April 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vaginoscope And Accessories
Device Class
Class II
Regulation Number
884.1630
Review Panel
OB
Submission Type

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Other clearances for product code MOK

  • K950639 — KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CA (June 19, 1995)