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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 K231401
Device Name Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
Applicant
Poly Medicure Limited
Plot # 115-116, Sector-59, Hsiidc Industrial Area
Ballabgarh
Faridabad,  IN 121004
Applicant Contact Ramdas Sharma
Correspondent
Gsa2 Group, LLC
8049 Hayes St. NE
Minneapolis,  MN  55432
Correspondent Contact Sunita Teekasingh
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/15/2023
Decision Date 09/21/2023
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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