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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 K851482
Device Name TOURNIQUET
Applicant
Polymer Technology Corp.
369 N. Newcomb St.
Whitwater,  WI  53190
Applicant Contact PLEKENPO L
Correspondent
Polymer Technology Corp.
369 N. Newcomb St.
Whitwater,  WI  53190
Correspondent Contact PLEKENPO L
Regulation Number878.5900
Classification Product Code
GAX  
Date Received04/15/1985
Decision Date 04/29/1985
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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