FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAYFIELD MR/X-RAY SKULL CLAMP
K Number: K081401
·
Decision Oct 8, 2008
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
49
Applicant Total
29
Review Days
142
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Basic Information
- Device Name
- MAYFIELD MR/X-RAY SKULL CLAMP
- K Number
- K081401
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4460
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra Lifesciences Corp.
- Date Received
- May 19, 2008
- Decision Date
- October 8, 2008
- Product Code
- HBL
- 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 |
|---|---|---|---|
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | FDA class 2 | Neurology |
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