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St. Louis Band

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161138
510(k) Type
Traditional
Applicant
ORTHOMERICA PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/20/2016
Days to Decision
89 days
Submission Type
Summary

St. Louis Band

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161138
510(k) Type
Traditional
Applicant
ORTHOMERICA PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/20/2016
Days to Decision
89 days
Submission Type
Summary