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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 K003187
Device Name VACUCATH I.V. CATHETER INTRODUCTER
Applicant
Auto/Cath Vascular Access, Inc.
21092 Bake Pkwy.
Suite 110
Lake Forest,  CA  92630
Applicant Contact ANIL BHALANI
Correspondent
Auto/Cath Vascular Access, Inc.
21092 Bake Pkwy.
Suite 110
Lake Forest,  CA  92630
Correspondent Contact ANIL BHALANI
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received10/11/2000
Decision Date 05/21/2001
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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