FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VOICE MASTER PROSTHESIS
K Number: K974132
·
Decision Feb 25, 1998
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
39
Applicant Total
3
Review Days
114
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Basic Information
- Device Name
- VOICE MASTER PROSTHESIS
- K Number
- K974132
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3730
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- E. Benson Hood Lab, Inc.
- Date Received
- November 3, 1997
- Decision Date
- February 25, 1998
- Product Code
- EWL
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EWL | Prosthesis, Laryngeal (Taub) | FDA class 2 | Ear, Nose, Throat |
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