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Disposable Monopolar Laparoscopic Shafts and Reusable Handles

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210569
510(k) Type
Traditional
Applicant
Dannik, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/16/2021
Days to Decision
171 days
Submission Type
Summary

Disposable Monopolar Laparoscopic Shafts and Reusable Handles

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210569
510(k) Type
Traditional
Applicant
Dannik, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/16/2021
Days to Decision
171 days
Submission Type
Summary