FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUNBLOCKER SUNGLASSES
K Number: K950807
·
Decision May 24, 1995
Classifications
1
FEI Numbers
1390
Registration Numbers
1390
Same Product Code
645
Applicant Total
7
Review Days
91
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Basic Information
- Device Name
- SUNBLOCKER SUNGLASSES
- K Number
- K950807
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Blublocker Corp.
- Date Received
- February 22, 1995
- Decision Date
- May 24, 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.
NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
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 Blublocker Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K954659 | MOONSHADES SUNGLASSES | Jan 11, 1996 | Substantially Equivalent |
| K901160 | NUBALOO(R) SUNGLASSES | Jun 14, 1990 | Substantially Equivalent |
| K901161 | SOLAR SHADES(TM) SUNGLASSES | May 1, 1990 | Substantially Equivalent |
| K900383 | BULLET SUNGLASSES | Feb 13, 1990 | Substantially Equivalent |
| K900381 | COLORVISION SUNGLASSES | Feb 13, 1990 | Substantially Equivalent |
| K900382 | BLUBLOCKER SUNGLASSES | Feb 13, 1990 | Substantially Equivalent |