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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K844917
Device Name TURN NEEDLE INTRAVENOUS CANNUL, NUB, W/TUBING INTE
Applicant
Turn Needle Intl., Inc.
927 Lincoln Rd.
Suite 110
Miami Beach,  FL  33139
Applicant Contact VAN AUKEN
Correspondent
Turn Needle Intl., Inc.
927 Lincoln Rd.
Suite 110
Miami Beach,  FL  33139
Correspondent Contact VAN AUKEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/19/1984
Decision Date 02/07/1985
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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