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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K070116
Device Name POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE
Applicant
Smiths Medical MD, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact PHIL NEURURER
Correspondent
Smiths Medical MD, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact PHIL NEURURER
Regulation Number880.5965
Classification Product Code
LJT  
Subsequent Product Code
FPA  
Date Received01/12/2007
Decision Date 05/23/2007
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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