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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 K912860
Device Name INTRAVASCULAR ADMINISTRATION SETS
Applicant
Pacific Device, Inc.
8572 Spectrum Ln.
San Diego,  CA  92121
Applicant Contact JIM CAPUTO
Correspondent
Pacific Device, Inc.
8572 Spectrum Ln.
San Diego,  CA  92121
Correspondent Contact JIM CAPUTO
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/27/1991
Decision Date 08/28/1991
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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