FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECTACLE FRAME
K Number: K911332
·
Decision May 6, 1991
Classifications
1
FEI Numbers
1086
Registration Numbers
1086
Same Product Code
197
Applicant Total
8
Review Days
41
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Basic Information
- Device Name
- SPECTACLE FRAME
- K Number
- K911332
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5842
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Australian Optical Co., Inc.
- Date Received
- March 26, 1991
- Decision Date
- May 6, 1991
- 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 OR EYEGLASS FRAMES
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SPECTACLE FRAME
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OPTICAL FRAMES
FDA 510(k)
FDA Class 1
·Ophthalmic
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 |
| K943641 | SPECTACLE FRAME | 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 |
| K910179 | OPTICAL FRAME | Apr 10, 1991 | Substantially Equivalent |