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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 K872003
Device Name KINDERWRAP
Applicant
The Kinder Co.
411 Greenlawn
Ypsilanti,  MI  48198
Applicant Contact TIM KINDER
Correspondent
The Kinder Co.
411 Greenlawn
Ypsilanti,  MI  48198
Correspondent Contact TIM KINDER
Regulation Number878.5900
Classification Product Code
GAX  
Date Received05/26/1987
Decision Date 06/23/1987
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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