FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ITEM # 754 HOT FLIP SHADES
K Number: K931389
·
Decision Oct 6, 1993
Classifications
1
FEI Numbers
1390
Registration Numbers
1390
Same Product Code
645
Applicant Total
6
Review Days
202
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ITEM # 754 HOT FLIP SHADES
- K Number
- K931389
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ja-Ru, Inc.
- Date Received
- March 18, 1993
- Decision Date
- October 6, 1993
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQY), ordered by most recent decision date.
NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
MULTI
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Ja-Ru, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941682 | COOL KIDS BEADS AND SHADES | May 17, 1994 | Substantially Equivalent |
| K935919 | SUNGLASSES | Feb 16, 1994 | Substantially Equivalent |
| K934402 | COOL KIDS MIRROR SHADES | Jan 25, 1994 | Substantially Equivalent |
| K935165 | BIKER MICE SUNGLASSES | Jan 6, 1994 | Substantially Equivalent |
| K934852 | COOL KIDS HIP SHADES | Dec 8, 1993 | Substantially Equivalent |