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510(k) K150518

Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm by Dupaco, Inc. — Product Code JXL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2015
Date Received
March 2, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Bite
Device Class
Class II
Regulation Number
882.5070
Review Panel
NE
Submission Type

Other clearances by Dupaco, Inc.

  • K841581 — UNIFILTER ANESTHESIA & RESPIRATORY FILT (April 30, 1984)
  • K830395 — PEEPER (March 11, 1983)
  • K821434 — EKG (ECG) ELECTRODES (July 30, 1982)
  • K770084 — OPERATING ROOM VENTILATOR (February 23, 1977)

Other clearances for product code JXL

  • K221469 — PATI (Protector Against Tongue Injury) (February 22, 2023)
  • K201309 — ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium (June 4, 2021)
  • K172978 — SurgeoBite (December 22, 2017)
  • K050188 — EPIGUARD (April 27, 2005)
  • K992269 — VENTIL-A ORAL PROTECTOR (October 25, 1999)
  • K960663 — UNIVERSAL BITE BLOCK (May 17, 1996)
  • K954352 — BITE BLOCK (January 25, 1996)
  • K941856 — PREMIER PROMAX BITE GUARD (April 5, 1995)
  • K924333 — THE DAVIS DISPOSABLE PROTECTIVE SPLINT (April 23, 1993)
  • K924304 — BITE BLOCK (April 6, 1993)