FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUNDT-KEES REINFORCING ANEURYSM CLIP
K Number: K844352
·
Decision Jan 24, 1985
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
35
Applicant Total
1
Review Days
76
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Basic Information
- Device Name
- SUNDT-KEES REINFORCING ANEURYSM CLIP
- K Number
- K844352
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5200
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Kees Surgical Specialty Co., Inc.
- Date Received
- November 9, 1984
- Decision Date
- January 24, 1985
- Product Code
- HCH
- 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 |
|---|---|---|---|
| HCH | Clip, Aneurysm | FDA class 2 | Neurology |
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