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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K220312
Device Name Polyfusion IV Administration Sets
Applicant
Poly Medicure Limited
Plot # Pa 010-018, 010-019, Mahindra World City (Jaipur)
Ltd.
Jaipur,  IN 302237
Applicant Contact Ramdas Sharma
Correspondent
Donawa Lifescience Consluting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/02/2022
Decision Date 04/12/2023
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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