FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EYEOPENER
K Number: K904469
·
Decision Jun 28, 1991
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
4
Applicant Total
1
Review Days
270
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Basic Information
- Device Name
- EYEOPENER
- K Number
- K904469
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Kc Medical Industries
- Date Received
- October 1, 1990
- Decision Date
- June 28, 1991
- Product Code
- JYJ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| JYJ | Gauge, Measuring | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JYJ), ordered by most recent decision date.
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