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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 K883902
Device Name INFUSA-PLATE
Applicant
Kalajian Ent.
5266 Appian Way
Long Beach,  CA  90803
Applicant Contact W KALAYJIAN
Correspondent
Kalajian Ent.
5266 Appian Way
Long Beach,  CA  90803
Correspondent Contact W KALAYJIAN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/15/1988
Decision Date 10/27/1988
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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