The following data is part of a premarket notification filed by Scott All-sports, Inc. with the FDA for Mouthpiece Breathing (performance Mouthguard).
| Device ID | K883416 |
| 510k Number | K883416 |
| Device Name: | MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) |
| Classification | Block, Bite |
| Applicant | SCOTT ALL-SPORTS, INC. 120 PROFESSIONAL DR. West Monroe, LA 71291 -5389 |
| Contact | Scott, Dds |
| Correspondent | Scott, Dds SCOTT ALL-SPORTS, INC. 120 PROFESSIONAL DR. West Monroe, LA 71291 -5389 |
| Product Code | JXL |
| CFR Regulation Number | 882.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1988-10-12 |