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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 K101329
Device Name SYNERGY CT 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 Received05/12/2010
Decision Date 08/19/2010
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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