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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
Recalls CDRH Recalls
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