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SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122932
510(k) Type
Traditional
Applicant
FOGLESS INTERNATIONAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
12/23/2013
Days to Decision
455 days
Submission Type
Statement

SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122932
510(k) Type
Traditional
Applicant
FOGLESS INTERNATIONAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
12/23/2013
Days to Decision
455 days
Submission Type
Statement