FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE LENS OR OMMI-GARD
K Number: K800521
·
Decision Mar 12, 1980
Classifications
1
FEI Numbers
602
Registration Numbers
602
Same Product Code
55
Applicant Total
3
Review Days
6
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Basic Information
- Device Name
- THE LENS OR OMMI-GARD
- K Number
- K800521
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5844
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Gentex Corporation
- Date Received
- March 6, 1980
- Decision Date
- March 12, 1980
- Product Code
- HQG
- 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 |
|---|---|---|---|
| HQG | Lens, Spectacle, Non-Custom (Prescription) | FDA class 1 | Ophthalmic |
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