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T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button

Page Type
Cleared 510(K)
510(k) Number
K231404
510(k) Type
Traditional
Applicant
Healthium Medtech Limited
Country
India
FDA Decision
Substantially Equivalent
Decision Date
8/4/2023
Days to Decision
81 days
Submission Type
Summary

T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button

Page Type
Cleared 510(K)
510(k) Number
K231404
510(k) Type
Traditional
Applicant
Healthium Medtech Limited
Country
India
FDA Decision
Substantially Equivalent
Decision Date
8/4/2023
Days to Decision
81 days
Submission Type
Summary