FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Oral Device OA, Oral Device S
K Number: K181396
·
Decision Nov 16, 2018
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
212
Applicant Total
1
Review Days
171
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Basic Information
- Device Name
- Oral Device OA, Oral Device S
- K Number
- K181396
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Passion For Life Healthcare (Uk) Limited
- Date Received
- May 29, 2018
- Decision Date
- November 16, 2018
- Product Code
- LRK
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| LRK | Device, Anti-Snoring | FDA class 2 | Dental |
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