FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Tear Pool Dissolvable Punctum Plugs
K Number: K190210
·
Decision Oct 24, 2019
Classifications
1
FEI Numbers
37
Registration Numbers
38
Same Product Code
48
Applicant Total
4
Review Days
262
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Basic Information
- Device Name
- Tear Pool Dissolvable Punctum Plugs
- K Number
- K190210
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alphamed, Inc.
- Date Received
- February 4, 2019
- Decision Date
- October 24, 2019
- Product Code
- LZU
- 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 |
|---|---|---|---|
| LZU | Plug, Punctum | FDA unclassified | Unknown |
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