HEART HUGGER STERNUM SUPPORT HARNESS— 510(k) K882592

Name: FDA 510(k) clearance K882592
Creator: U.S. Food and Drug Administration
Published: 1988-09-20

Substantially Equivalent

General Cardiac Technology, Inc.

FDA 510(k) clearance K882592 for HEART HUGGER STERNUM SUPPORT HARNESS, Substantially Equivalent on 1988-09-20. Applicant: General Cardiac Technology, Inc.. Device class: 1.

Clearance details

Applicant: General Cardiac Technology, Inc.
Product code: Code KMO
Device class: Class 1
Regulation: 21 CFR 880.5160
Advisory panel: General Hospital
Date received: 1988-06-23
Decision date: 1988-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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