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PacEndo EDTA

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153528
510(k) Type
Traditional
Applicant
PAC-DENT INTERNATIONAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/1/2016
Days to Decision
54 days
Submission Type
Summary

PacEndo EDTA

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153528
510(k) Type
Traditional
Applicant
PAC-DENT INTERNATIONAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/1/2016
Days to Decision
54 days
Submission Type
Summary