The following data is part of a premarket notification filed by Inventive Resources, Inc. with the FDA for Dr. Hays Bite Guard.
| Device ID | K014079 |
| 510k Number | K014079 |
| Device Name: | DR. HAYS BITE GUARD |
| Classification | Mouthguard, Prescription |
| Applicant | INVENTIVE RESOURCES, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf INVENTIVE RESOURCES, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-11 |
| Decision Date | 2002-02-22 |
| Summary: | summary |