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PuraStat-OM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210211
510(k) Type
Traditional
Applicant
3-D Matrix, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/8/2021
Days to Decision
254 days
Submission Type
Summary

PuraStat-OM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210211
510(k) Type
Traditional
Applicant
3-D Matrix, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/8/2021
Days to Decision
254 days
Submission Type
Summary