OXFORD MARK 2 EXTERNAL FIXATOR— 510(k) K833114

Name: FDA 510(k) clearance K833114
Creator: U.S. Food and Drug Administration
Published: 1983-10-20

Substantially Equivalent

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K833114 for OXFORD MARK 2 EXTERNAL FIXATOR, Substantially Equivalent on 1983-10-20. Applicant: Johnson & Johnson Professionals, Inc.. Device class: 2.

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1983-09-13
Decision date: 1983-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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