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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K851017
Device Name QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU
Applicant
Quest Medical, Inc.
3312 Wiley Post Rd.
Carrollton,  TX  75006
Applicant Contact WILLIAM A FRANKLIN
Correspondent
Quest Medical, Inc.
3312 Wiley Post Rd.
Carrollton,  TX  75006
Correspondent Contact WILLIAM A FRANKLIN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/12/1985
Decision Date 05/07/1985
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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