FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORVIS KEY WEST SUNGLASSES
K Number: K950609
·
Decision Mar 2, 1995
Classifications
1
FEI Numbers
1390
Registration Numbers
1390
Same Product Code
645
Applicant Total
9
Review Days
20
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Basic Information
- Device Name
- ORVIS KEY WEST SUNGLASSES
- K Number
- K950609
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Orvis Co., Inc.
- Date Received
- February 10, 1995
- Decision Date
- March 2, 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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·Ophthalmic
Other Clearances by The Orvis Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943161 | ORVIS DRIVING GLASSES | Aug 4, 1994 | Substantially Equivalent |
| K943131 | ORVIS POLARIZED BI-FOCALS | Aug 2, 1994 | Substantially Equivalent |
| K942951 | ORVIS LIGHT WEIGHT POLARIZED CLIP-ONS | Aug 2, 1994 | Substantially Equivalent |
| K942952 | ORVIS WORLD FINEST POLARIZED CLIP ONS | Jul 25, 1994 | Substantially Equivalent |
| K941910 | SUNGLASSES | Jul 8, 1994 | Substantially Equivalent |
| K941751 | SUNGLASSES | Jun 3, 1994 | Substantially Equivalent |
| K940354 | ORVIS MARQUESAS FISHING GLASSES | Mar 24, 1994 | Substantially Equivalent |
| K940292 | ORVIS RIVER GUIDE GLASSES | Mar 24, 1994 | Substantially Equivalent |