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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, Short-Term Less Than 30 Days
510(k) Number K052389
Device Name I-PORT
Applicant
Patton Medical Devices
P.O. Box 1490
Eagle,  ID  83616
Applicant Contact FRED SCHLADOR
Correspondent
Tuv America, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Correspondent Contact LAURA DANIELSON
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/31/2005
Decision Date 09/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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