BURNETT-KETCHUM DYNAMIC HAND EXERCISER— 510(k) K790527

Name: FDA 510(k) clearance K790527
Creator: U.S. Food and Drug Administration
Published: 1979-03-22

Substantially Equivalent

Maddak, Inc.

FDA 510(k) clearance K790527 for BURNETT-KETCHUM DYNAMIC HAND EXERCISER, Substantially Equivalent on 1979-03-22. Applicant: Maddak, Inc.. Device class: 1.

Clearance details

Applicant: Maddak, Inc.
Product code: Code JFA
Device class: Class 1
Regulation: 21 CFR 890.5410
Advisory panel: Physical Medicine
Date received: 1979-03-15
Decision date: 1979-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.