FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POLARON
K Number: K902187
·
Decision Aug 8, 1990
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
6
Applicant Total
3
Review Days
86
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Basic Information
- Device Name
- POLARON
- K Number
- K902187
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5900
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Nurion Industries
- Date Received
- May 14, 1990
- Decision Date
- August 8, 1990
- Product Code
- HPG
- 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 |
|---|---|---|---|
| HPG | Aid, Vision, Electronic, Battery-Powered | FDA class 1 | Ophthalmic |
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