Skip to contentDe Novo DEN130046
- Device
- REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE
- Contact
- james s. miller
- De Novo number
- DEN130046
- Product code
- PKA
- Regulation
- 874.5900
- Classification name
- external upper esophageal sphincter (ues) compression device
- Decision
- granted (DENG)
- Decision date
- 2015-03-06
- Date received
- 2013-11-14
- Classification advisory
- Ear Nose & Throat
- Review advisory
- Ear Nose & Throat
- Type
- Direct
Current FDA Classification#
- Product code
- PKA
- Device name
- External Upper Esophageal Sphincter (Ues) Compression Device
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation
- 874.5900
- Implant
- N
- Life sustain/support
- N