510(k) K150518
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