FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSCAR, MODEL OE3000
K Number: K021502
·
Decision Jun 6, 2002
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
6
Applicant Total
4
Review Days
28
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Basic Information
- Device Name
- OSCAR, MODEL OE3000
- K Number
- K021502
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.4580
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthosonics, Ltd.
- Date Received
- May 9, 2002
- Decision Date
- June 6, 2002
- Product Code
- LZV
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| LZV | System, Cement Removal Extraction | FDA class 2 | Orthopedic |
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