MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM— 510(k) K911911

Name: FDA 510(k) clearance K911911
Creator: U.S. Food and Drug Administration
Published: 1992-03-20

Substantially Equivalent

Medical Design & Manufacturing Corp.

FDA 510(k) clearance K911911 for MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM, Substantially Equivalent on 1992-03-20. Applicant: Medical Design & Manufacturing Corp.. Device class: 2.

Clearance details

Applicant: Medical Design & Manufacturing Corp.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1991-04-30
Decision date: 1992-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westerville, OH, US

Download summary PDF View on FDA.gov ↗

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