MARK 20 AND MARK 25 HAND ENGINE CONTROLLER— 510(k) K964860

Name: FDA 510(k) clearance K964860
Creator: U.S. Food and Drug Administration
Published: 1997-03-03

Substantially Equivalent

Bell Intl., Inc.

FDA 510(k) clearance K964860 for MARK 20 AND MARK 25 HAND ENGINE CONTROLLER, Substantially Equivalent on 1997-03-03. Applicant: Bell Intl., Inc.. Device class: 1.

Clearance details

Applicant: Bell Intl., Inc.
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 1996-12-04
Decision date: 1997-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlingame, CA, US

Download summary PDF View on FDA.gov ↗

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