FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS
K Number: K983607
·
Decision Jan 8, 1999
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
13
Applicant Total
3
Review Days
86
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Basic Information
- Device Name
- LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS
- K Number
- K983607
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5700
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Labtician Ophthalmics, Inc.
- Date Received
- October 14, 1998
- Decision Date
- January 8, 1999
- Product Code
- MML
- 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 |
|---|---|---|---|
| MML | Weights, Eyelid, External | FDA class 2 | Ophthalmic |
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