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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K130034
Device Name UNI-PICC
Applicant
Health Line International Corporation
803 N. 1250 W.
Suite 1
Centerville,  UT  84014
Applicant Contact NOLA BENSTOG
Correspondent
Health Line International Corporation
803 N. 1250 W.
Suite 1
Centerville,  UT  84014
Correspondent Contact NOLA BENSTOG
Regulation Number880.5970
Classification Product Code
LJS  
Date Received01/07/2013
Decision Date 03/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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