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510(k) K032988

ELPHA 4 CONTI by Danmeter A/S — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2003
Date Received
September 24, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Device Class
Class II
Regulation Number
876.5320
Review Panel
GU
Submission Type

Other clearances by Danmeter A/S

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  • K032954 — ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 (August 9, 2004)
  • K032955 — AUTOMOVE, MODEL AM800 (December 15, 2003)

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  • K230983 — Unicare (K-UNICARE-USA) (October 20, 2023)