FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SODEM HIGH SPEED SYSTEM
K Number: K954080
·
Decision Oct 16, 1995
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
55
Applicant Total
3
Review Days
46
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Basic Information
- Device Name
- SODEM HIGH SPEED SYSTEM
- K Number
- K954080
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sodem Diffusion SA
- Date Received
- August 31, 1995
- Decision Date
- October 16, 1995
- Product Code
- HSZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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