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ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K060657
510(k) Type
Special
Applicant
BREAS MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
8/18/2006
Days to Decision
158 days
Submission Type
Summary

ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K060657
510(k) Type
Special
Applicant
BREAS MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
8/18/2006
Days to Decision
158 days
Submission Type
Summary