FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
SHIELD, EYE, OPHTHALMIC
K Number: K945351
·
Decision Dec 13, 1994
Classifications
1
FEI Numbers
712
Registration Numbers
712
Same Product Code
54
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- SHIELD, EYE, OPHTHALMIC
- K Number
- K945351
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4750
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Taiwan Eva Industrial Co., Inc.
- Date Received
- September 14, 1994
- Decision Date
- December 13, 1994
- Product Code
- HOY
- 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 |
|---|---|---|---|
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | FDA class 1 | Ophthalmic |
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