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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K980583
Device Name EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE
Applicant
Sims Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact DAVID H SHORT
Correspondent
Sims Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact DAVID H SHORT
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/17/1998
Decision Date 04/27/1998
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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