FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIESSE LARYNGEAL IMPLANT
K Number: K070090
·
Decision Mar 1, 2007
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
16
Applicant Total
3
Review Days
50
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Basic Information
- Device Name
- RADIESSE LARYNGEAL IMPLANT
- K Number
- K070090
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioform Medical, Inc.
- Date Received
- January 10, 2007
- Decision Date
- March 1, 2007
- Product Code
- MIX
- 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 |
|---|---|---|---|
| MIX | System, Vocal Cord Medialization | FDA class 2 | Ear, Nose, Throat |
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