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BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061099
510(k) Type
Traditional
Applicant
HOFFMAN LABORATORIES, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/11/2006
Days to Decision
114 days
Submission Type
Summary

BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061099
510(k) Type
Traditional
Applicant
HOFFMAN LABORATORIES, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/11/2006
Days to Decision
114 days
Submission Type
Summary