The following data is part of a premarket notification filed by Smartguard, Inc. with the FDA for Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard Elite.
| Device ID | K123161 |
| 510k Number | K123161 |
| Device Name: | SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE |
| Classification | Mouthguard, Prescription |
| Applicant | SMARTGUARD, INC. 601 BRICKELL KEY DRIVE SUITE 104 Miami, FL 33131 |
| Contact | Shelly Garg |
| Correspondent | Shelly Garg SMARTGUARD, INC. 601 BRICKELL KEY DRIVE SUITE 104 Miami, FL 33131 |
| 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 | 2012-10-09 |
| Decision Date | 2013-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10866330000205 | K123161 | 000 |