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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 K955552
Device Name EXPRESSAIRE TORUNIQUET SYSTEM
Applicant
SMITH & NEPHEW RICHARDS, INC.
2925 APPLING RD.
BARTLETT,  TN  38133
Applicant Contact RONALD K SMITH
Correspondent
SMITH & NEPHEW RICHARDS, INC.
2925 APPLING RD.
BARTLETT,  TN  38133
Correspondent Contact RONALD K SMITH
Regulation Number878.5910
Classification Product Code
KCY  
Date Received12/05/1995
Decision Date 01/05/1996
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
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