FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
SUNGLASSES
K Number: K910329
·
Decision Mar 12, 1991
Classifications
1
FEI Numbers
664
Registration Numbers
664
Same Product Code
10
Applicant Total
1
Review Days
46
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Basic Information
- Device Name
- SUNGLASSES
- K Number
- K910329
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5840
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Cutler & Gross Sloan Optical , Ltd.
- Date Received
- January 25, 1991
- Decision Date
- March 12, 1991
- Product Code
- HOI
- 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 |
|---|---|---|---|
| HOI | Spectacle, Magnifying | FDA class 1 | Ophthalmic |
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