FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
K Number: K802651
·
Decision Dec 17, 1980
Classifications
1
FEI Numbers
602
Registration Numbers
602
Same Product Code
55
Applicant Total
34
Review Days
54
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Basic Information
- Device Name
- POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
- K Number
- K802651
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5844
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Chiron Vision Corp.
- Date Received
- October 24, 1980
- Decision Date
- December 17, 1980
- Product Code
- HQG
- 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 |
|---|---|---|---|
| HQG | Lens, Spectacle, Non-Custom (Prescription) | FDA class 1 | Ophthalmic |
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