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FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160540
510(k) Type
Traditional
Applicant
FLEXICARE MEDICAL LIMITED
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
6/23/2016
Days to Decision
118 days
Submission Type
Summary

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160540
510(k) Type
Traditional
Applicant
FLEXICARE MEDICAL LIMITED
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
6/23/2016
Days to Decision
118 days
Submission Type
Summary