GORE INTRODUCER SHEATH— 510(k) K013282

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K013282 for GORE INTRODUCER SHEATH, Substantially Equivalent on 2001-12-14. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code DBY
Advisory panel: Immunology
Date received: 2001-10-02
Decision date: 2001-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

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