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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 K914988
Device Name 500 INFUSER
Applicant
EXCEL MEDICAL, INC.
P.O. BOX 1353
ASBURY PARK,  NJ  07712
Applicant Contact MARGARET LUMIA
Correspondent
EXCEL MEDICAL, INC.
P.O. BOX 1353
ASBURY PARK,  NJ  07712
Correspondent Contact MARGARET LUMIA
Regulation Number880.5725
Classification Product Code
FRN  
Date Received11/06/1991
Decision Date 04/06/1992
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
Recalls CDRH Recalls
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