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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 K954201
Device Name BUONAFEDE PNEUMATIC SLEEVE
Applicant
Promedic, Inc.
67920 Klinger Lake Rd.
Sturgis,  MI  49091 -9288
Applicant Contact PAUL E DRYDEN
Correspondent
Promedic, Inc.
67920 Klinger Lake Rd.
Sturgis,  MI  49091 -9288
Correspondent Contact PAUL E DRYDEN
Regulation Number878.5910
Classification Product Code
KCY  
Date Received09/06/1995
Decision Date 11/09/1995
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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