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510(k) DEN000006

EROS-CLITORAL THERAPY DEVICE (CTD) by Urometrics, Inc. — Product Code NBV

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 28, 2000
Date Received
April 27, 2000
Clearance Type
Post-NSE
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 by Urometrics, Inc.

  • K980627 — NEVA SYSTEM (April 7, 1998)
  • K971790 — KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM) (December 17, 1997)

Other clearances for product code NBV

  • K043480 — ENHANCE CLITORAL STIMULATION AID (June 8, 2005)
  • K001576 — EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY (December 28, 2000)