FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION)
K Number: K914407
·
Decision Dec 31, 1991
Classifications
1
FEI Numbers
1390
Registration Numbers
1390
Same Product Code
645
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION)
- K Number
- K914407
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Promedex, Inc.
- Date Received
- October 2, 1991
- Decision Date
- December 31, 1991
- Product Code
- HQY
- 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 |
|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | FDA class 1 | Ophthalmic |
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