REUSABLE FOGARTY FLEXIBLE CALIBRATOR— 510(k) K822687

Name: FDA 510(k) clearance K822687
Creator: U.S. Food and Drug Administration
Published: 1982-10-04

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K822687 for REUSABLE FOGARTY FLEXIBLE CALIBRATOR, Substantially Equivalent on 1982-10-04. Applicant: American Edwards Laboratories. Device class: 2.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code DWP
Device class: Class 2
Regulation: 21 CFR 870.4475
Advisory panel: Cardiovascular
Date received: 1982-09-03
Decision date: 1982-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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