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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K230616
Device Name Polyguard and Polyshield Safety IV Catheters
Applicant
Poly Medicure Limited
Plot # 115-116, Sector-59, Hsiidc Industrial Area
Ballabgarh
Faridabad,  IN 121004
Applicant Contact Ramdas Sharma
Correspondent
Donawa Lifescience Consulting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/06/2023
Decision Date 05/05/2023
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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