The following data is part of a premarket notification filed by Univ. Dental Assoc. Department Of Orthodontics with the FDA for Removable Herbst Appliance.
| Device ID | K955822 |
| 510k Number | K955822 |
| Device Name: | REMOVABLE HERBST APPLIANCE |
| Classification | Device, Anti-snoring |
| Applicant | UNIV. DENTAL ASSOC. DEPARTMENT OF ORTHODONTICS 140 SQUIRE HALL Buffalo, NY 14214 |
| Contact | Stephen P Warunek |
| Correspondent | Stephen P Warunek UNIV. DENTAL ASSOC. DEPARTMENT OF ORTHODONTICS 140 SQUIRE HALL Buffalo, NY 14214 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-26 |
| Decision Date | 1996-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810002220272 | K955822 | 000 |