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SleepRight ProRx Custom Dental Guard

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193577
510(k) Type
Traditional
Applicant
Splintek, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/1/2020
Days to Decision
161 days
Submission Type
Summary

SleepRight ProRx Custom Dental Guard

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193577
510(k) Type
Traditional
Applicant
Splintek, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/1/2020
Days to Decision
161 days
Submission Type
Summary