The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Removable Arylic Herbst, Allesee Snore Appliance (asa), And Enoch Snorinator.
| Device ID | K070327 |
| 510k Number | K070327 |
| Device Name: | REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR |
| Classification | Device, Anti-snoring |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-05 |
| Decision Date | 2007-05-25 |
| Summary: | summary |