The following data is part of a premarket notification filed by Dupaco Inc. with the FDA for Airway With Bite Block And Tongue Depressor 80 Mm, Airway With Bite Block And Tongue Depressor 90 Mm.
| Device ID | K150518 |
| 510k Number | K150518 |
| Device Name: | Airway With Bite Block And Tongue Depressor 80 Mm, Airway With Bite Block And Tongue Depressor 90 Mm |
| Classification | Block, Bite |
| Applicant | DUPACO INC. 4144 AVENIDA DE LA PLATA Oceanside, CA 92056 |
| Contact | An Vu |
| Correspondent | Greg Holland REGULATORY SPECIALIST, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | JXL |
| CFR Regulation Number | 882.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-02 |
| Decision Date | 2015-06-29 |
| Summary: | summary |