FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GOLD FOIL ERG ELECTRODES
K Number: K820254
·
Decision Apr 9, 1982
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
10
Applicant Total
46
Review Days
67
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Basic Information
- Device Name
- GOLD FOIL ERG ELECTRODES
- K Number
- K820254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1220
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Cadwell Laboratories, Inc.
- Date Received
- February 1, 1982
- Decision Date
- April 9, 1982
- Product Code
- HLZ
- 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 |
|---|---|---|---|
| HLZ | Electrode, Corneal | FDA class 2 | Ophthalmic |
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