The following data is part of a premarket notification filed by Specialty Appliance Works, Inc. with the FDA for Acrylic Herbst Splint Appliance.
| Device ID | K083209 |
| 510k Number | K083209 |
| Device Name: | ACRYLIC HERBST SPLINT APPLIANCE |
| Classification | Device, Anti-snoring |
| Applicant | SPECIALTY APPLIANCE WORKS, INC. 4905 HAMMOND INDUSTRIAL DRIVE Cumming, GA 30041 |
| Contact | Carolyn Thomas |
| Correspondent | Carolyn Thomas SPECIALTY APPLIANCE WORKS, INC. 4905 HAMMOND INDUSTRIAL DRIVE Cumming, GA 30041 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-31 |
| Decision Date | 2009-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D85463400TS1 | K083209 | 000 |
| D85463280AS1 | K083209 | 000 |
| D85463280S1 | K083209 | 000 |
| D85463300S1 | K083209 | 000 |
| D85463310S1 | K083209 | 000 |
| D85463312S1 | K083209 | 000 |
| D85463313S1 | K083209 | 000 |
| D85463316AS1 | K083209 | 000 |
| D85463316EAS1 | K083209 | 000 |
| D85463316ES1 | K083209 | 000 |
| D85463316GS1 | K083209 | 000 |
| D85463316S1 | K083209 | 000 |
| D85463320S1 | K083209 | 000 |
| D85463400S1 | K083209 | 000 |
| D85463270S1 | K083209 | 000 |