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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 K934640
Device Name HMP DUAL POLYSULFONE PORT
Applicant
Horizon Medical Products, Inc.
4200 Northside Pkwy. NW
Atlanta,  GA  30327
Applicant Contact RODDY J H. CLARK
Correspondent
Horizon Medical Products, Inc.
4200 Northside Pkwy. NW
Atlanta,  GA  30327
Correspondent Contact RODDY J H. CLARK
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/28/1993
Decision Date 02/25/1994
Decision Substantially Equivalent - Kit (SESK)
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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