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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 K953225
Device Name IVAC BALL VALCE ADMIN. SETS
Applicant
Y
10300 Campus Pt. Dr.
San Diego,  CA  92121
Applicant Contact JENNIFER S HANKARD
Correspondent
Y
10300 Campus Pt. Dr.
San Diego,  CA  92121
Correspondent Contact JENNIFER S HANKARD
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/10/1995
Decision Date 09/27/1995
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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