FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FAMILY OF DISPOSABLE LENSES
K Number: K140368
·
Decision Apr 29, 2014
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
9
Applicant Total
3
Review Days
74
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Basic Information
- Device Name
- FAMILY OF DISPOSABLE LENSES
- K Number
- K140368
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1660
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sensor Medical Technology, LLC
- Date Received
- February 14, 2014
- Decision Date
- April 29, 2014
- Product Code
- HKS
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HKS | Prism, Gonioscopic | FDA class 1 | Ophthalmic |
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