ORCA (tm) - Operational Rescue Containment Apparatus

Chamber, Patient Isolation

ISOVAC PRODUCTS, LLC

The following data is part of a premarket notification filed by Isovac Products, Llc with the FDA for Orca (tm) - Operational Rescue Containment Apparatus.

Pre-market Notification Details

Device IDK163223
510k NumberK163223
Device Name:ORCA (tm) - Operational Rescue Containment Apparatus
ClassificationChamber, Patient Isolation
Applicant ISOVAC PRODUCTS, LLC 1306 ENTERPRISE DRIVE, UNIT C Romeoville,  IL  60446
ContactPeter M. Jenkner
CorrespondentJeffery Jones
JL JONES GROUP, INC 1213 KEVINGTON DRIVE Antioch,  IL  60002
Product CodeLGM  
CFR Regulation Number880.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-16
Decision Date2017-11-02
Summary:summary

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