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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 K932095
Device Name PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S
Applicant
PHARMACIA DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Applicant Contact DAVID H SHORT
Correspondent
PHARMACIA DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Correspondent Contact DAVID H SHORT
Regulation Number880.5965
Classification Product Code
LJT  
Date Received04/30/1993
Decision Date 01/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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