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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Air, Medical Recirculating
510(k) Number K843435
Device Name LABMASTER & CRSI 600
Applicant
CONTROL RESOURCE SYSTEMS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CONTROL RESOURCE SYSTEMS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5045
Classification Product Code
FRF  
Date Received09/04/1984
Decision Date 05/15/1985
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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