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GM501 SpermAir and GM501 SpermActive

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192644
510(k) Type
Traditional
Applicant
Hamilton Thorne Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/23/2020
Days to Decision
212 days
Submission Type
Summary

GM501 SpermAir and GM501 SpermActive

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192644
510(k) Type
Traditional
Applicant
Hamilton Thorne Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/23/2020
Days to Decision
212 days
Submission Type
Summary