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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 K993463
Device Name INTRAVASCULAR ADMINISTRATION SET
Applicant
CUSTOM ASSEMBLIES, INC.
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055
Applicant Contact PAUL E DRYDEN
Correspondent
CUSTOM ASSEMBLIES, INC.
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055
Correspondent Contact PAUL E DRYDEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/13/1999
Decision Date 01/04/2000
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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