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510(k) K093218

FEMEYE TWO by Fem Suite, LLC — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2010
Date Received
October 13, 2009
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 Fem Suite, LLC

  • K062563 — FEMTEN CERVICAL TENACULUM (May 18, 2007)

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