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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 K852073
Device Name VIAL SYRINGE PUMPS, SE200, SE200B & SE400
Applicant
Hospal Medical Corp.
25 Kimberly Rd.
P.O. Box 857
East Brunswick,  NJ  08816
Applicant Contact FRESSINET
Correspondent
Hospal Medical Corp.
25 Kimberly Rd.
P.O. Box 857
East Brunswick,  NJ  08816
Correspondent Contact FRESSINET
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/13/1985
Decision Date 06/07/1985
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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