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510(k) K123330

IOGYN ENDOSCOPE by Iogyn, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2013
Date Received
October 26, 2012
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 Iogyn, Inc.

  • K141848 — IOGYN SYSTEM (August 29, 2014)
  • DEN130040 — IOGYN SYSTEM (March 28, 2014)

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