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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Pump, Infusion
510(k) Number K220695
Device Name Elite Biomedical Solutions Dose Request Cord
Applicant
Elite Biomedical Solutions
756 Cincinnati-Batavia Pike, Suite C
Cincinnati,  OH  45245
Applicant Contact Brenda Compliment
Correspondent
Elite Biomedical Solutions
756 Cincinnati-Batavia Pike, Suite C
Cincinnati,  OH  45245
Correspondent Contact Brenda Compliment
Regulation Number880.5725
Classification Product Code
MRZ  
Date Received03/09/2022
Decision Date 04/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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