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SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123161
510(k) Type
Traditional
Applicant
SMARTGUARD, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/14/2013
Days to Decision
156 days
Submission Type
Summary

SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123161
510(k) Type
Traditional
Applicant
SMARTGUARD, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/14/2013
Days to Decision
156 days
Submission Type
Summary