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510(k) K163223

ORCA (tm) - Operational Rescue Containment Apparatus by Isovac Products, LLC — Product Code LGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2017
Date Received
November 16, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Patient Isolation
Device Class
Class II
Regulation Number
880.5450
Review Panel
HO
Submission Type

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