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ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201884
510(k) Type
Traditional
Applicant
Microline Surgical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/21/2020
Days to Decision
105 days
Submission Type
Summary

ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201884
510(k) Type
Traditional
Applicant
Microline Surgical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/21/2020
Days to Decision
105 days
Submission Type
Summary