SURGICUTT - BLEEDING TIME DEVICE— 510(k) K850542

Name: FDA 510(k) clearance K850542
Creator: U.S. Food and Drug Administration
Published: 1985-03-01

Substantially Equivalent

International Technidyne Corp.

FDA 510(k) clearance K850542 for SURGICUTT - BLEEDING TIME DEVICE, Substantially Equivalent on 1985-03-01. Applicant: International Technidyne Corp.. Device class: 2.

Clearance details

Applicant: International Technidyne Corp.
Product code: Code JCA
Device class: Class 2
Regulation: 21 CFR 864.6100
Advisory panel: Hematology
Date received: 1985-02-11
Decision date: 1985-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

Download summary PDF View on FDA.gov ↗

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