The following data is part of a premarket notification filed by Crane Dental Laboratory, Inc. with the FDA for Crane Acrylic Herbst Appliance.
| Device ID | K140429 |
| 510k Number | K140429 |
| Device Name: | CRANE ACRYLIC HERBST APPLIANCE |
| Classification | Device, Anti-snoring |
| Applicant | CRANE DENTAL LABORATORY, INC. 200 AIRPARK DRIVE, SUITE 30 Rochester, NY 14624 |
| Contact | Kate Young |
| Correspondent | Kate Young CRANE DENTAL LABORATORY, INC. 200 AIRPARK DRIVE, SUITE 30 Rochester, NY 14624 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-19 |
| Decision Date | 2014-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009255616 | K140429 | 000 |