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Acrylic Herbst Appliance with Micro-Recorder

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170606
510(k) Type
Traditional
Applicant
Gergen's Orthodontic Lab
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/16/2017
Days to Decision
260 days
Submission Type
Summary

Acrylic Herbst Appliance with Micro-Recorder

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170606
510(k) Type
Traditional
Applicant
Gergen's Orthodontic Lab
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/16/2017
Days to Decision
260 days
Submission Type
Summary