The following data is part of a premarket notification filed by Gergen's Orthodontic Lab with the FDA for Acrylic Herbst Appliance With Micro-recorder.
| Device ID | K170606 |
| 510k Number | K170606 |
| Device Name: | Acrylic Herbst Appliance With Micro-Recorder |
| Classification | Sleep Appliances With Patient Monitoring |
| Applicant | Gergen's Orthodontic Lab 1745 West Deer Valley Rd, Suite 112 Phoenix, AZ 85027 |
| Contact | Chris Morrison |
| Correspondent | Karen E. Warden BackRoads Consulting PO Box 566 Chesterland, OH 44026 *0566 |
| Product Code | PLC |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-01 |
| Decision Date | 2017-11-16 |
| Summary: | summary |