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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K850503
Device Name SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS
Applicant
Turn Needle Intl., Inc.
927 Lincoln Rd.
Suite 110
Miami Beach,  FL  33139
Applicant Contact PETER PIOWONKA
Correspondent
Turn Needle Intl., Inc.
927 Lincoln Rd.
Suite 110
Miami Beach,  FL  33139
Correspondent Contact PETER PIOWONKA
Regulation Number880.5210
Classification Product Code
KMK  
Date Received02/08/1985
Decision Date 04/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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