FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
INTELIPORT OCCLUDING DEVICE
K Number: K040231
·
Decision Jul 13, 2004
Classifications
1
FEI Numbers
37
Registration Numbers
38
Same Product Code
48
Applicant Total
3
Review Days
162
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Basic Information
- Device Name
- INTELIPORT OCCLUDING DEVICE
- K Number
- K040231
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alcon, Inc.
- Date Received
- February 2, 2004
- Decision Date
- July 13, 2004
- 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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