FDA 510(k) Applications for Medical Device Product Code "JXL"
(Block, Bite)

FDA 510(k) Number Applicant Device Name Decision Date
K960663 B & B MEDICAL TECHNOLOGIES, INC. UNIVERSAL BITE BLOCK 05/17/1996
K150518 DUPACO INC. Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm 06/29/2015
K050188 EPISAFE MEDICAL DEVICES, LTD. EPIGUARD 04/27/2005
K201309 MECTA Corporation ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium 06/04/2021
K221469 NeuroVice, LLC PATI (Protector Against Tongue Injury) 02/22/2023
K992269 SOMATICS, INC. VENTIL-A ORAL PROTECTOR 10/25/1999
K172978 Surgovations LLC SurgeoBite 12/22/2017
K954352 UNITED STATES ENDOSCOPY GROUP, INC. BITE BLOCK 01/25/1996


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