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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K950284
Device Name SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR
Applicant
Sims Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact LISA J STONE
Correspondent
Sims Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact LISA J STONE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/24/1995
Decision Date 05/23/1995
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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