FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
LOWE KLEARWAY
K Number: K950763
·
Decision May 25, 1995
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
194
Applicant Total
1
Review Days
97
Basic Information
- Device Name
- LOWE KLEARWAY
- K Number
- K950763
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- DR. ALAN A. LOWE, INC.
- Date Received
- February 17, 1995
- Decision Date
- May 25, 1995
- 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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