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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 K942303
Device Name TECNADYNE T-CUFF
Applicant
Technadyne Scientific, Inc.
546 1st St.
Vero Beach,  FL  32962
Applicant Contact JOHN R GARRETT
Correspondent
Technadyne Scientific, Inc.
546 1st St.
Vero Beach,  FL  32962
Correspondent Contact JOHN R GARRETT
Regulation Number878.5910
Classification Product Code
KCY  
Date Received05/13/1994
Decision Date 07/20/1994
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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