Cleared Traditional

HEART HUGGER STERNUM SUPPORT HARNESS

K882592 · General Cardiac Technology, Inc. · General Hospital
Sep 1988
Decision
89d
Days
Class 1
Risk

About This 510(k) Submission

K882592 is an FDA 510(k) clearance for the HEART HUGGER STERNUM SUPPORT HARNESS, a Binder, Elastic (Class I — General Controls, product code KMO), submitted by General Cardiac Technology, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 20, 1988, 89 days after receiving the submission on June 23, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5160.

Submission Details

510(k) Number K882592 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1988
Decision Date September 20, 1988
Days to Decision 89 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code KMO — Binder, Elastic
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.5160