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I-NEB AAD SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K042991
510(k) Type
Traditional
Applicant
PROFILE THERAPEUTICS PLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/23/2005
Days to Decision
326 days
Submission Type
Summary

I-NEB AAD SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K042991
510(k) Type
Traditional
Applicant
PROFILE THERAPEUTICS PLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/23/2005
Days to Decision
326 days
Submission Type
Summary