PHANTOM XL INSULATED DILATORS— 510(k) K140088

Substantially Equivalent

Tedan Surgical Innovations, LLC

FDA 510(k) clearance K140088 for PHANTOM XL INSULATED DILATORS, Substantially Equivalent on 2014-09-25. Applicant: Tedan Surgical Innovations, LLC.

Clearance details

Applicant: Tedan Surgical Innovations, LLC
Product code: Code PDQ
Advisory panel: Ear, Nose, Throat
Date received: 2014-01-14
Decision date: 2014-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Land, TX, US

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