FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Lacriflow CL
K Number: K170247
·
Decision Apr 18, 2017
Classifications
1
FEI Numbers
20
Registration Numbers
21
Same Product Code
30
Applicant Total
4
Review Days
81
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Basic Information
- Device Name
- Lacriflow CL
- K Number
- K170247
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kaneka Pharma America, LLC
- Date Received
- January 27, 2017
- Decision Date
- April 18, 2017
- Product Code
- OKS
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| OKS | Lacrimal Stents And Intubation Sets | FDA unclassified | Unknown |
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