FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BONE CEMENT RADIO-OPACIFIER
K Number: K032388
·
Decision Oct 31, 2003
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
32
Review Days
88
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Basic Information
- Device Name
- BONE CEMENT RADIO-OPACIFIER
- K Number
- K032388
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5300
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardinalhealth
- Date Received
- August 4, 2003
- Decision Date
- October 31, 2003
- Product Code
- MYU
- 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 |
|---|---|---|---|
| MYU | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty | FDA class 2 | Neurology |
Similar 510(k) Clearances
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