Clearance Summary
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES received FDA 510(k) clearance under submission number K082206, sponsored by Helix Medical, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2008-09-04.
- Submission: K082206
- Applicant / Sponsor: Helix Medical, LLC
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3730
- Decision date: 2008-09-04
Classification & Regulation
This clearance is catalogued under FDA product code EWL and 21 CFR 874.3730, within the Ear, Nose, Throat review panel as a Class II device.