The following data is part of a premarket notification filed by Elba Laboratories, Inc. with the FDA for Wired Mouth Protector (wmp).
| Device ID | K131396 |
| 510k Number | K131396 |
| Device Name: | WIRED MOUTH PROTECTOR (WMP) |
| Classification | Intraoral, Dental Foam Protector |
| Applicant | ELBA LABORATORIES, INC. 780 W. 8 MILE RD Ferndale, MI 48220 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer ELBA LABORATORIES, INC. 780 W. 8 MILE RD Ferndale, MI 48220 |
| Product Code | PFL |
| CFR Regulation Number | 872.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-15 |
| Decision Date | 2013-09-30 |
| Summary: | summary |