FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
OCCU-FLO PUNCTUM PLUGS
K Number: K001768
·
Decision Sep 19, 2000
Classifications
1
FEI Numbers
37
Registration Numbers
38
Same Product Code
48
Applicant Total
4
Review Days
99
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OCCU-FLO PUNCTUM PLUGS
- K Number
- K001768
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- U.S. Iol, Inc.
- Date Received
- June 12, 2000
- Decision Date
- September 19, 2000
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZU), ordered by most recent decision date.
Hello,eyes® BIO Plug
FDA 510(k)
FDA Unclassified
·Unknown
Visant Medical Canalicular Plug
FDA 510(k)
FDA Unclassified
·Unknown
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
FDA 510(k)
FDA Unclassified
·Unknown
Tear Pool Dissolvable Punctum Plugs
FDA 510(k)
FDA Unclassified
·Unknown
Soft Plug Extended Duration 180 Canalicular Plug
FDA 510(k)
FDA Unclassified
·Unknown
LacriPro Punctum Plug
FDA 510(k)
FDA Unclassified
·Unknown