FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EVANS ARM AND HAND REST
K Number: K760697
·
Decision Nov 2, 1976
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
1
Applicant Total
47
Review Days
41
Basic Information
- Device Name
- EVANS ARM AND HAND REST
- K Number
- K760697
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4855
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Alcon Laboratories
- Date Received
- September 22, 1976
- Decision Date
- November 2, 1976
- Product Code
- HRK
- 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 |
|---|---|---|---|
| HRK | Table, Instrument, Manual, Ophthalmic | FDA class 1 | Ophthalmic |
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