FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VENETO COLLECTION
K Number: K912034
·
Decision Aug 22, 1991
Classifications
1
FEI Numbers
1086
Registration Numbers
1086
Same Product Code
197
Applicant Total
3
Review Days
106
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Basic Information
- Device Name
- VENETO COLLECTION
- K Number
- K912034
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5842
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Atlantic Optical Co., Inc.
- Date Received
- May 8, 1991
- Decision Date
- August 22, 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 |
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