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

K150518 is an FDA 510(k) premarket notification submitted by Dupaco, Inc. for the device "Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm". The FDA issued a decision of Substantially Equivalent on June 29, 2015. The device falls under product code JXL (Block, Bite), a Class II device regulated under 21 CFR 882.5070. Dupaco, Inc. has at least 4 other 510(k) clearances on record.

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