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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 K970485
Device Name SMARTSITE ACCESS PIN
Applicant
IVAC MEDICAL SYSTEMS
10221 WATERIDGE CIRCLE
san diego,  CA  92121
Applicant Contact renee l fluet
Correspondent
IVAC MEDICAL SYSTEMS
10221 WATERIDGE CIRCLE
san diego,  CA  92121
Correspondent Contact renee l fluet
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/10/1997
Decision Date 04/21/1997
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
Recalls CDRH Recalls
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