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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 K973862
Device Name PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS
Applicant
Sims Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact LISA STONE
Correspondent
Sims Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact LISA STONE
Regulation Number880.5965
Classification Product Code
LJT  
Date Received10/09/1997
Decision Date 12/29/1997
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
Recalls CDRH Recalls
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