FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
K Number: K030289
·
Decision Feb 26, 2003
Classifications
1
FEI Numbers
68
Registration Numbers
69
Same Product Code
257
Applicant Total
29
Review Days
29
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Basic Information
- Device Name
- HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
- K Number
- K030289
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra Lifesciences Corp.
- Date Received
- January 28, 2003
- Decision Date
- February 26, 2003
- Product Code
- JXG
- 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 |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | FDA class 2 | Neurology |
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