E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES— 510(k) K921885

Name: FDA 510(k) clearance K921885
Creator: U.S. Food and Drug Administration
Published: 1994-03-25

Substantially Equivalent

Valleylab, Inc.

FDA 510(k) clearance K921885 for E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES, Substantially Equivalent on 1994-03-25. Applicant: Valleylab, Inc.. Device class: 2.

Clearance details

Applicant: Valleylab, Inc.
Product code: Code HGZ
Device class: Class 2
Regulation: 21 CFR 884.5390
Advisory panel: Obstetrics/Gynecology
Date received: 1992-04-21
Decision date: 1994-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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