FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ETHICON LACRIMAL STENT
K Number: K812255
·
Decision Aug 20, 1981
Classifications
1
FEI Numbers
154
Registration Numbers
154
Same Product Code
9
Applicant Total
204
Review Days
8
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Basic Information
- Device Name
- ETHICON LACRIMAL STENT
- K Number
- K812255
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- ETHICON, Inc.
- Date Received
- August 12, 1981
- Decision Date
- August 20, 1981
- Product Code
- HNL
- Advisory Committee
- Ophthalmic
- 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 |
|---|---|---|---|
| HNL | Probe, Lachrymal | FDA class 1 | Ophthalmic |
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