HI-TOPS ELECTRODES 14-8000— 510(k) K935947

Name: FDA 510(k) clearance K935947
Creator: U.S. Food and Drug Administration
Published: 1994-02-28

Substantially Equivalent

W. J. Medical Instruments, Inc.

FDA 510(k) clearance K935947 for HI-TOPS ELECTRODES 14-8000, Substantially Equivalent on 1994-02-28. Applicant: W. J. Medical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: W. J. Medical Instruments, Inc.
Product code: Code KNF
Device class: Class 2
Regulation: 21 CFR 884.4160
Advisory panel: Obstetrics/Gynecology
Date received: 1993-12-13
Decision date: 1994-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newbury Park, CA, US

Download summary PDF View on FDA.gov ↗

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