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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 K875276
Device Name PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM
Applicant
Pharmacia Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact EDWARD NUMAINVILLE
Correspondent
Pharmacia Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact EDWARD NUMAINVILLE
Regulation Number880.5965
Classification Product Code
LJT  
Date Received12/24/1987
Decision Date 04/13/1988
Decision Substantially Equivalent (SESE)
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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