FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANEUROPLASTIC, MODEL 43-1290
K Number: K071776
·
Decision Jul 26, 2007
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
152
Review Days
27
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Basic Information
- Device Name
- ANEUROPLASTIC, MODEL 43-1290
- K Number
- K071776
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5030
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Codman & Shurtleff, Inc.
- Date Received
- June 29, 2007
- Decision Date
- July 26, 2007
- Product Code
- JXH
- 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 |
|---|---|---|---|
| JXH | Methyl Methacrylate For Aneurysmorrhaphy | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JXH), ordered by most recent decision date.
ORTHOPAEDIC AND SPINAL RING CURRETTES
FDA 510(k)
FDA Class 2
·Neurology
ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL
FDA 510(k)
FDA Class 2
·Neurology
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