NONIMPLANTED ELECTRICAL CONTINENCE DEVICE— 510(k) K891007

Substantially Equivalent

Tridak Division of Indicon, Inc.

FDA 510(k) clearance K891007 for NONIMPLANTED ELECTRICAL CONTINENCE DEVICE, Substantially Equivalent on 1990-06-07. Applicant: Tridak Division of Indicon, Inc.. Device class: 2.

Clearance details

Applicant
Tridak Division of Indicon, Inc.
Product code
Code KPI
Device class
Class 2
Regulation
21 CFR 876.5320
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Williston, VT, US
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