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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 K982587
Device Name MPS FIXED FLOW RATE SET
Applicant
Medical Product Specialists
499 Nibus St., Suite E
Brea,  CA  92821
Applicant Contact DAN HYUN
Correspondent
Medical Product Specialists
499 Nibus St., Suite E
Brea,  CA  92821
Correspondent Contact DAN HYUN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/24/1998
Decision Date 08/24/1998
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
Predetermined Change
Control Plan Authorized		 No
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