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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 K944133
Device Name MTB 1043 TREATMENT BOOTH
Applicant
Mark Solutions, Inc.
87 Rte. 17 N.
Maywood,  NJ  07607
Applicant Contact JOSEPH L FERRARO
Correspondent
Mark Solutions, Inc.
87 Rte. 17 N.
Maywood,  NJ  07607
Correspondent Contact JOSEPH L FERRARO
Regulation Number880.5450
Classification Product Code
LGM  
Date Received08/24/1994
Decision Date 09/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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