The following data is part of a premarket notification filed by Frantz Design, Inc. with the FDA for Elastic Mandibular Advancement - Titration (ema-t) Appilance.
| Device ID | K973884 |
| 510k Number | K973884 |
| Device Name: | ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE |
| Classification | Device, Anti-snoring |
| Applicant | FRANTZ DESIGN, INC. 400 MEDICAL CENTER, #209 Webster, TX 77598 |
| Contact | Donald Frantz |
| Correspondent | Donald Frantz FRANTZ DESIGN, INC. 400 MEDICAL CENTER, #209 Webster, TX 77598 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-14 |
| Decision Date | 1998-01-09 |
| Summary: | summary |