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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 K080695
Device Name MOBILE I.V. SYSTEMS 10,20,60
Applicant
Northwind Technologies, Corp.
20171 Bowens Rd.
Manchester,  MI  48158
Applicant Contact DAWN I MOORE
Correspondent
Northwind Technologies, Corp.
20171 Bowens Rd.
Manchester,  MI  48158
Correspondent Contact DAWN I MOORE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/11/2008
Decision Date 07/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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