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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tourniquet, Pneumatic
510(k) Number K953953
Device Name DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF
Applicant
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Applicant Contact MITZI Y SHEARER
Correspondent
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Correspondent Contact MITZI Y SHEARER
Regulation Number878.5910
Classification Product Code
KCY  
Date Received08/22/1995
Decision Date 09/29/1995
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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