TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.)— 510(k) K970014

Name: FDA 510(k) clearance K970014
Creator: U.S. Food and Drug Administration
Published: 1997-08-06

Substantially Equivalent

Delphi Consulting Group

FDA 510(k) clearance K970014 for TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.), Substantially Equivalent on 1997-08-06. Applicant: Delphi Consulting Group. Device class: 2.

Clearance details

Applicant: Delphi Consulting Group
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 1997-01-02
Decision date: 1997-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.