KALMATE MODEL 3A— 510(k) K854476

Name: FDA 510(k) clearance K854476
Creator: U.S. Food and Drug Administration
Published: 1986-02-27

Substantially Equivalent

Medical Technology Systems, Inc.

FDA 510(k) clearance K854476 for KALMATE MODEL 3A, Substantially Equivalent on 1986-02-27. Applicant: Medical Technology Systems, Inc.. Device class: 2.

Clearance details

Applicant: Medical Technology Systems, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1985-11-07
Decision date: 1986-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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