FDA 510(k)
FDA class 1
Substantially Equivalent
🇭🇰 Hong Kong
NIL
K Number: K943263
·
Decision Aug 15, 1994
Classifications
1
FEI Numbers
1390
Registration Numbers
1390
Same Product Code
645
Applicant Total
2
Review Days
39
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Basic Information
- Device Name
- NIL
- K Number
- K943263
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sing Wah International Enterprises , Ltd.
- Date Received
- July 7, 1994
- Decision Date
- August 15, 1994
- 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
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MULTI
FDA 510(k)
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Other Clearances by Sing Wah International Enterprises , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K943613 | NIL | Sep 21, 1994 | Substantially Equivalent |