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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K232886
Device Name INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
Applicant
Healthium Medtech Limited
472-D, 13th Cross, 4th Phase, Peenya Industrial Area
Bangalore,  IN 560058
Applicant Contact Pankaj Dawar
Correspondent
Healthium Medtech Limited
472-D, 13th Cross, 4th Phase, Peenya Industrial Area
Bangalore,  IN 560058
Correspondent Contact Pankaj Dawar
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/18/2023
Decision Date 11/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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