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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, Intraperitoneal
510(k) Number K832906
Device Name PORT-A-CATH IMPLANTABLE CATHETER SYS
Applicant
PHARMACIA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PHARMACIA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5965
Classification Product Code
LLD  
Date Received08/29/1983
Decision Date 03/06/1984
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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