FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LARS AC Band Device
K Number: K190143
·
Decision Nov 4, 2019
Classifications
1
FEI Numbers
272
Registration Numbers
272
Same Product Code
92
Applicant Total
57
Review Days
279
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Basic Information
- Device Name
- LARS AC Band Device
- K Number
- K190143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corin USA
- Date Received
- January 29, 2019
- Decision Date
- November 4, 2019
- Product Code
- HTN
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HTN | Washer, Bolt Nut | FDA class 2 | Orthopedic |
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