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TRANQUIL TRI-BTE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061459
510(k) Type
Special
Applicant
GENERAL HEARING INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/30/2006
Days to Decision
35 days
Submission Type
Statement

TRANQUIL TRI-BTE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061459
510(k) Type
Special
Applicant
GENERAL HEARING INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/30/2006
Days to Decision
35 days
Submission Type
Statement