The following data is part of a premarket notification filed by Somatics, Inc. with the FDA for Somatics Mouth Guard (bite Block).
| Device ID | K864181 |
| 510k Number | K864181 |
| Device Name: | SOMATICS MOUTH GUARD (BITE BLOCK) |
| Classification | Block, Bite |
| Applicant | SOMATICS, INC. 910 SHERWOOD DR., UNIT 17 Lake Bluff, IL 60044 |
| Contact | Abrams, M.d. |
| Correspondent | Abrams, M.d. SOMATICS, INC. 910 SHERWOOD DR., UNIT 17 Lake Bluff, IL 60044 |
| Product Code | JXL |
| CFR Regulation Number | 882.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-27 |
| Decision Date | 1986-11-03 |