FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUNGLASSES
K Number: K864543
·
Decision Mar 13, 1987
Classifications
1
FEI Numbers
1390
Registration Numbers
1390
Same Product Code
645
Applicant Total
1
Review Days
114
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Basic Information
- Device Name
- SUNGLASSES
- K Number
- K864543
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Image of Hawaii
- Date Received
- November 19, 1986
- Decision Date
- March 13, 1987
- Product Code
- HQY
- 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 |
|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | FDA class 1 | Ophthalmic |
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