FDA 510(k), K171239, TULA Tube Delivery System

510(K) Number: K171239
Device Name: TULA Tube Delivery System
Manufacturer: Pavan Sethi
Device Classification Name: Tube, Tympanostomy
Regulation Number: ETD
Classification Product Code: KXA
Date Received: 04/27/2017
Decision Date: 06/28/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat

102 pages (261 of 363 original pages are fully redacted)