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PROVOX 2 VOICE PROSTHESIS SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K971244
510(k) Type
Traditional
Applicant
ATOS MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
6/6/1997
Days to Decision
64 days
Submission Type
Statement

PROVOX 2 VOICE PROSTHESIS SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K971244
510(k) Type
Traditional
Applicant
ATOS MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
6/6/1997
Days to Decision
64 days
Submission Type
Statement