FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUNGLASSES, NON-PRESCRIPTION (ITALO CREMONA)
K Number: K910126
·
Decision Mar 14, 1991
Classifications
1
FEI Numbers
1390
Registration Numbers
1390
Same Product Code
645
Applicant Total
5
Review Days
66
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Basic Information
- Device Name
- SUNGLASSES, NON-PRESCRIPTION (ITALO CREMONA)
- K Number
- K910126
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- The Limited Stores, Inc.
- Date Received
- January 7, 1991
- Decision Date
- March 14, 1991
- 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.
NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
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NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
MULTI
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by The Limited Stores, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941875 | SUNGLASSES | Jun 3, 1994 | Substantially Equivalent |
| K910125 | SUNGLASSES/NON-PRESCRIPTION (LA GIARDINIERA) | Mar 14, 1991 | Substantially Equivalent |
| K910127 | SUNGLASSES, NON-PRESCRIPTION (POLINELLI) | Mar 14, 1991 | Substantially Equivalent |
| K905864 | SUNGLASSES (NON-PRESCRIPTION) | Mar 14, 1991 | Substantially Equivalent |