FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEMLITE (PLASTIC EYEGLASS FRAMES)
K Number: K770221
·
Decision Feb 17, 1977
Classifications
1
FEI Numbers
1086
Registration Numbers
1086
Same Product Code
197
Applicant Total
35
Review Days
14
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Basic Information
- Device Name
- MEMLITE (PLASTIC EYEGLASS FRAMES)
- K Number
- K770221
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5842
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- American Optical Corp.
- Date Received
- February 3, 1977
- Decision Date
- February 17, 1977
- Product Code
- HQZ
- 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 |
|---|---|---|---|
| HQZ | Frame, Spectacle | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQZ), ordered by most recent decision date.
VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW
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SPECTACLE FRAME
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SPECTACLE FRAME OR EYEGLASS FRAMES
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SPECTACLE FRAME
FDA 510(k)
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OPTICAL FRAMES
FDA 510(k)
FDA Class 1
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FRAME, SPECTACLES
FDA 510(k)
FDA Class 1
·Ophthalmic
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