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HALO 360 & SIZING BALLOON, MODEL 3441C

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K093855
510(k) Type
Special
Applicant
Barrx Medical, Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/15/2010
Days to Decision
30 days
Submission Type
Summary

HALO 360 & SIZING BALLOON, MODEL 3441C

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K093855
510(k) Type
Special
Applicant
Barrx Medical, Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/15/2010
Days to Decision
30 days
Submission Type
Summary