FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES
K Number: K082206
·
Decision Sep 4, 2008
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
39
Applicant Total
4
Review Days
30
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Basic Information
- Device Name
- BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES
- K Number
- K082206
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.3730
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Helix Medical, LLC
- Date Received
- August 5, 2008
- Decision Date
- September 4, 2008
- 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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