FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL
K Number: K873688
·
Decision Oct 26, 1987
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
279
Review Days
46
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Basic Information
- Device Name
- ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL
- K Number
- K873688
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5030
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Dentsply Intl.
- Date Received
- September 10, 1987
- Decision Date
- October 26, 1987
- 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.
ANEUROPLASTIC, MODEL 43-1290
FDA 510(k)
FDA Class 2
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ORTHOPAEDIC AND SPINAL RING CURRETTES
FDA 510(k)
FDA Class 2
·Neurology
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