FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX
K Number: K052387
·
Decision Nov 29, 2005
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
4
Applicant Total
348
Review Days
90
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Basic Information
- Device Name
- ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX
- K Number
- K052387
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrex, Inc.
- Date Received
- August 31, 2005
- Decision Date
- November 29, 2005
- Product Code
- LZB
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LZB | Finger Cot | FDA class 1 | General Hospital |
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