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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 K974013
Device Name EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE
Applicant
Sims Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact EDWARD W NUMAINVILLE
Correspondent
Sims Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact EDWARD W NUMAINVILLE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/22/1997
Decision Date 12/17/1997
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
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