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510(k) K001576

EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY by Prosurg, Inc. — Product Code NBV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2000
Date Received
May 22, 2000
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

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Other clearances for product code NBV

  • K043480 — ENHANCE CLITORAL STIMULATION AID (June 8, 2005)
  • DEN000006 — EROS-CLITORAL THERAPY DEVICE (CTD) (April 28, 2000)