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EM SA Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191201
510(k) Type
Traditional
Applicant
Hiossen, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/15/2019
Days to Decision
193 days
Submission Type
Summary

EM SA Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191201
510(k) Type
Traditional
Applicant
Hiossen, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/15/2019
Days to Decision
193 days
Submission Type
Summary