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PERFORMAX TOTAL FACE MASK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103395
510(k) Type
Special
Applicant
RESPIRONICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/24/2011
Days to Decision
125 days
Submission Type
Summary

PERFORMAX TOTAL FACE MASK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103395
510(k) Type
Special
Applicant
RESPIRONICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/24/2011
Days to Decision
125 days
Submission Type
Summary