The following data is part of a premarket notification filed by Bionix Development Corp. with the FDA for Truguard Custom Tongue And Jaw Positioner.
| Device ID | K153270 |
| 510k Number | K153270 |
| Device Name: | TruGuard Custom Tongue And Jaw Positioner |
| Classification | Accelerator, Linear, Medical |
| Applicant | BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612 |
| Contact | James Huttner |
| Correspondent | James Huttner BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-12 |
| Decision Date | 2016-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817740021038 | K153270 | 000 |
| 10817740020949 | K153270 | 000 |
| 10714646000412 | K153270 | 000 |