GRAHAM-FIELD SALINE ELECTROLYTE GEL— 510(k) K944600

Name: FDA 510(k) clearance K944600
Creator: U.S. Food and Drug Administration
Published: 1995-11-20

Substantially Equivalent

Chester Labs, Inc.

FDA 510(k) clearance K944600 for GRAHAM-FIELD SALINE ELECTROLYTE GEL, Substantially Equivalent on 1995-11-20. Applicant: Chester Labs, Inc.. Device class: 2.

Clearance details

Applicant: Chester Labs, Inc.
Product code: Code GYB
Device class: Class 2
Regulation: 21 CFR 882.1275
Advisory panel: Neurology
Date received: 1994-09-19
Decision date: 1995-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Erlanger, KY, US

Download summary PDF View on FDA.gov ↗

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