DI CUSTOM IN THE EAR AND IN THE CANAL— 510(k) K920657

Name: FDA 510(k) clearance K920657
Creator: U.S. Food and Drug Administration
Published: 1992-03-31

Substantially Equivalent

Dakota Laboratories, Inc.

FDA 510(k) clearance K920657 for DI CUSTOM IN THE EAR AND IN THE CANAL, Substantially Equivalent on 1992-03-31. Applicant: Dakota Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Dakota Laboratories, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1992-02-12
Decision date: 1992-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Andes, SD, US

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