Last synced on 9 December 2022 at 11:04 pm

MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K013737
510(k) Type
Special
Applicant
TELEMED SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/1/2002
Days to Decision
108 days
Submission Type
Summary

MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K013737
510(k) Type
Special
Applicant
TELEMED SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/1/2002
Days to Decision
108 days
Submission Type
Summary