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510(k) K043480

ENHANCE CLITORAL STIMULATION AID by Gynavations, Inc. — Product Code NBV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2005
Date Received
December 16, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Engorgement, Clitoral
Device Class
Class II
Regulation Number
884.5970
Review Panel
OB
Submission Type

Other clearances for product code NBV

  • K001576 — EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY (December 28, 2000)
  • DEN000006 — EROS-CLITORAL THERAPY DEVICE (CTD) (April 28, 2000)