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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Patient Isolation
510(k) Number K163223
Device Name ORCA (tm) - Operational Rescue Containment Apparatus
Applicant
ISOVAC PRODUCTS, LLC
1306 ENTERPRISE DRIVE, UNIT C
ROMEOVILLE,  IL  60446
Applicant Contact PETER M. JENKNER
Correspondent
JL JONES GROUP, INC
1213 KEVINGTON DRIVE
ANTIOCH,  IL  60002
Correspondent Contact JEFFERY JONES
Regulation Number880.5450
Classification Product Code
LGM  
Date Received11/16/2016
Decision Date 11/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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