TRACE MODEL #'S 840, 841, 842, 845— 510(k) K925145

Name: FDA 510(k) clearance K925145
Creator: U.S. Food and Drug Administration
Published: 1993-05-19

Substantially Equivalent

Trace Medical Equipment, Inc.

FDA 510(k) clearance K925145 for TRACE MODEL #'S 840, 841, 842, 845, Substantially Equivalent on 1993-05-19. Applicant: Trace Medical Equipment, Inc.. Device class: 1.

Clearance details

Applicant: Trace Medical Equipment, Inc.
Product code: Code FYH
Device class: Class 1
Regulation: 21 CFR 878.3910
Advisory panel: General, Plastic Surgery
Date received: 1992-10-13
Decision date: 1993-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lisle, IL, US

Download summary PDF View on FDA.gov ↗

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