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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 K832755
Device Name INFUSION PUMP & IV SETS #4000
Applicant
OMNI-GLOW, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
OMNI-GLOW, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5725
Classification Product Code
FRN  
Date Received08/16/1983
Decision Date 11/03/1983
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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