FDA 510(k)
FDA unclassified
Substantially Equivalent
🇫🇷 France
LacriJet®
K Number: K201606
·
Decision Dec 18, 2020
Classifications
1
FEI Numbers
20
Registration Numbers
21
Same Product Code
30
Applicant Total
4
Review Days
186
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Basic Information
- Device Name
- LacriJet®
- K Number
- K201606
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fci (France Chirurgie Instrumentation) Sas
- Date Received
- June 15, 2020
- Decision Date
- December 18, 2020
- 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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