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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 K955839
Device Name MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER
Applicant
Baxter Edwards
17221 Red Hill Ave.
Irvine,  CA  92614 -5627
Applicant Contact IRENE PARKER
Correspondent
Baxter Edwards
17221 Red Hill Ave.
Irvine,  CA  92614 -5627
Correspondent Contact IRENE PARKER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/26/1995
Decision Date 03/25/1996
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
Recalls CDRH Recalls
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