STERI-SHURE— 510(k) K820147

Substantially Equivalent

General Health Systems, Inc.

FDA 510(k) clearance K820147 for STERI-SHURE, Substantially Equivalent on 1982-02-05. Applicant: General Health Systems, Inc.. Device class: 2.

Clearance details

Applicant: General Health Systems, Inc.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1982-01-19
Decision date: 1982-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.