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AERO-MASK ONE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K852626
510(k) Type
Traditional
Applicant
ASHAI CO. LTD.
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
9/18/1985
Days to Decision
90 days

AERO-MASK ONE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K852626
510(k) Type
Traditional
Applicant
ASHAI CO. LTD.
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
9/18/1985
Days to Decision
90 days