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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 K002786
Device Name BIOSENSORS CENTRAL VENOUS CATHETER KITS
Applicant
SUNSCOPE INTL., INC.
20250 ACACIA ST., SUITE 115
NEWPORT BEACH,  CA  92660
Applicant Contact JORGE HAIDER
Correspondent
SUNSCOPE INTL., INC.
20250 ACACIA ST., SUITE 115
NEWPORT BEACH,  CA  92660
Correspondent Contact JORGE HAIDER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/07/2000
Decision Date 11/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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