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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 K003854
Device Name INTRAVASCULAR ADMINISTRATION SET
Applicant
Infusion Devices, Inc.
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Applicant Contact PAUL E DRYDEN
Correspondent
Infusion Devices, Inc.
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Correspondent Contact PAUL E DRYDEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/13/2000
Decision Date 02/05/2001
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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