FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
PUNCTUAL OCCLUDER
K Number: K972523
·
Decision Sep 9, 1997
Classifications
1
FEI Numbers
37
Registration Numbers
38
Same Product Code
48
Applicant Total
4
Review Days
64
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Basic Information
- Device Name
- PUNCTUAL OCCLUDER
- K Number
- K972523
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Odyssey Medical, Inc.
- Date Received
- July 7, 1997
- Decision Date
- September 9, 1997
- 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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