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PROVOX(TM) VOICE PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K940638
510(k) Type
Traditional
Applicant
ATOS MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
6/22/1994
Days to Decision
128 days
Submission Type
Statement

PROVOX(TM) VOICE PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K940638
510(k) Type
Traditional
Applicant
ATOS MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
6/22/1994
Days to Decision
128 days
Submission Type
Statement