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510(k) K022260

FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS by Isolation Systems, Inc. — Product Code LGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2002
Date Received
June 28, 2002
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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