FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MASUNAGA OPTICAL MANUFACTURING
K Number: K862502
·
Decision Jul 11, 1986
Classifications
1
FEI Numbers
1086
Registration Numbers
1086
Same Product Code
197
Applicant Total
4
Review Days
10
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Basic Information
- Device Name
- MASUNAGA OPTICAL MANUFACTURING
- K Number
- K862502
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5842
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- South West Intl., Inc.
- Date Received
- July 1, 1986
- Decision Date
- July 11, 1986
- 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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