FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AVON SUNNY DAYS SUNGLASSES
K Number: K946092
·
Decision Jan 31, 1995
Classifications
1
FEI Numbers
1390
Registration Numbers
1390
Same Product Code
645
Applicant Total
5
Review Days
48
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Basic Information
- Device Name
- AVON SUNNY DAYS SUNGLASSES
- K Number
- K946092
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Siegel,Mandell & Davidson,P.C.
- Date Received
- December 14, 1994
- Decision Date
- January 31, 1995
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQY), ordered by most recent decision date.
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MULTI
FDA 510(k)
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Other Clearances by Siegel,Mandell & Davidson,P.C.
| K Number | Device Name | ||
|---|---|---|---|
| K951008 | POWER RANGERS SUNGLASSES | May 2, 1995 | Substantially Equivalent |
| K950931 | AVON MASSAGING HAIRBRUSH | Apr 5, 1995 | Substantially Equivalent for Some Indications |
| K946091 | AVON SUNNY DAYS SUNGLASSES | Jan 31, 1995 | Substantially Equivalent |
| K941369 | AVON CAT SUNGLASSES | May 17, 1994 | Substantially Equivalent |