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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tourniquet, Nonpneumatic
510(k) Number K843056
Device Name ELASTIC BANDAGE
Applicant
Sterile Medical Systems
541 Main St.
South Weymouth,  MA  02190
Applicant Contact GEORGE H WOODLAND
Correspondent
Sterile Medical Systems
541 Main St.
South Weymouth,  MA  02190
Correspondent Contact GEORGE H WOODLAND
Regulation Number878.5900
Classification Product Code
GAX  
Date Received08/03/1984
Decision Date 12/04/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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