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Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151123
510(k) Type
Traditional
Applicant
Pac-Dent International, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/3/2016
Days to Decision
310 days
Submission Type
Summary

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151123
510(k) Type
Traditional
Applicant
Pac-Dent International, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/3/2016
Days to Decision
310 days
Submission Type
Summary