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gammaCore-2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172270
510(k) Type
Traditional
Applicant
eletroCore, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/7/2017
Days to Decision
132 days
Submission Type
Summary

gammaCore-2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172270
510(k) Type
Traditional
Applicant
eletroCore, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/7/2017
Days to Decision
132 days
Submission Type
Summary