FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEVRAIN CRANIAL CLAMP
K Number: K971252
·
Decision Jul 6, 1998
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
55
Applicant Total
3
Review Days
459
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Basic Information
- Device Name
- SEVRAIN CRANIAL CLAMP
- K Number
- K971252
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5330
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ikonos Corp.
- Date Received
- April 3, 1997
- Decision Date
- July 6, 1998
- Product Code
- GXN
- 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 |
|---|---|---|---|
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | FDA class 2 | Neurology |
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