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510(k) K944133

MTB 1043 TREATMENT BOOTH by Mark Solutions, Inc. — Product Code LGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1995
Date Received
August 24, 1994
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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