Device Listing 1606196128
Listing Summary#
- Listing key
- 1606196128
- Premarket submission
- K082206
- Device
- BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES
- Applicant
- Helix Medical, LLC
- Product code
- EWL
- Decision date
- 2008-09-04