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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
510(k) Number K801979
Device Name ARGYLE COMPACT CHEST DRAINAGE SYSTEM
Applicant
Sherwood Medical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sherwood Medical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6740
Classification Product Code
GCX  
Date Received08/19/1980
Decision Date 09/16/1980
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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