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TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K043160
510(k) Type
Traditional
Applicant
TRACOE MEDICAL GMBH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/18/2005
Days to Decision
95 days
Submission Type
Statement

TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K043160
510(k) Type
Traditional
Applicant
TRACOE MEDICAL GMBH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/18/2005
Days to Decision
95 days
Submission Type
Statement