VOICE MASTER PROSTHESIS
FDA 510(k) clearance K974132 · decided 1998-02-25
Clearance details
- K-number
- K974132
- Device name
- VOICE MASTER PROSTHESIS
- Applicant
- E. Benson Hood Lab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-03
- Decision date
- 1998-02-25
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- EWL
- Device class
- 2
- Regulation number
- 874.3730
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Pembroke, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.