ORCA (tm) - Operational Rescue Containment Apparatus— 510(k) K163223

Name: FDA 510(k) clearance K163223
Creator: U.S. Food and Drug Administration
Published: 2017-11-02

Substantially Equivalent

Isovac Products, LLC

FDA 510(k) clearance K163223 for ORCA (tm) - Operational Rescue Containment Apparatus, Substantially Equivalent on 2017-11-02. Applicant: Isovac Products, LLC. Device class: 2.

Clearance details

Applicant: Isovac Products, LLC
Product code: Code LGM
Device class: Class 2
Regulation: 21 CFR 880.5450
Advisory panel: General Hospital
Date received: 2016-11-16
Decision date: 2017-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Romeoville, IL, US

Download summary PDF View on FDA.gov ↗

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