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BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201983
510(k) Type
Traditional
Applicant
Med-El Elektromedizinische Geraete GmbH
Country
Austria
FDA Decision
Substantially Equivalent
Decision Date
10/9/2020
Days to Decision
84 days
Submission Type
Summary

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201983
510(k) Type
Traditional
Applicant
Med-El Elektromedizinische Geraete GmbH
Country
Austria
FDA Decision
Substantially Equivalent
Decision Date
10/9/2020
Days to Decision
84 days
Submission Type
Summary