FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY
K Number: K954717
·
Decision Jan 22, 1997
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
26
Applicant Total
3
Review Days
467
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Basic Information
- Device Name
- SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY
- K Number
- K954717
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4370
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sodem Diffusion SA
- Date Received
- October 13, 1995
- Decision Date
- January 22, 1997
- Product Code
- HBB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HBB | Motor, Drill, Pneumatic | FDA class 2 | Neurology |
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