FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECTACLE FRAME
K Number: K943641
·
Decision Sep 14, 1994
Classifications
1
FEI Numbers
1086
Registration Numbers
1086
Same Product Code
197
Applicant Total
8
Review Days
49
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Basic Information
- Device Name
- SPECTACLE FRAME
- K Number
- K943641
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5842
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Australian Optical Co., Inc.
- Date Received
- July 27, 1994
- Decision Date
- September 14, 1994
- 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.
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OPTICAL FRAMES
FDA 510(k)
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FRAME, SPECTACLES
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Australian Optical Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943640 | SUNGLASS CLIP | Sep 14, 1994 | Substantially Equivalent |
| K943562 | SUNGLASSES | Sep 14, 1994 | Substantially Equivalent |
| K943561 | SPECTACLE FRAME | Sep 14, 1994 | Substantially Equivalent |
| K935678 | SUNGLASS FRAME | Feb 16, 1994 | Substantially Equivalent |
| K930331 | SPECTACLE FRAME | Dec 8, 1993 | Substantially Equivalent |
| K911332 | SPECTACLE FRAME | May 6, 1991 | Substantially Equivalent |
| K910179 | OPTICAL FRAME | Apr 10, 1991 | Substantially Equivalent |