FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BIOINSULATED SILICONE PUNCTUM PLUG
K Number: K001234
·
Decision Jul 11, 2000
Classifications
1
FEI Numbers
37
Registration Numbers
38
Same Product Code
48
Applicant Total
2
Review Days
85
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Basic Information
- Device Name
- BIOINSULATED SILICONE PUNCTUM PLUG
- K Number
- K001234
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Vision Science
- Date Received
- April 17, 2000
- Decision Date
- July 11, 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 |
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Other Clearances by Advanced Vision Science
| K Number | Device Name | ||
|---|---|---|---|
| K980844 | SURGIDEV SILICONE PUNCTUM PLUG | May 11, 1998 | Substantially Equivalent |