FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESTORE
K Number: K872164
·
Decision Sep 17, 1987
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
119
Applicant Total
1
Review Days
104
Basic Information
- Device Name
- RESTORE
- K Number
- K872164
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- ANDERSON RESEARCH, INC.
- Date Received
- June 5, 1987
- Decision Date
- September 17, 1987
- Product Code
- LPN
- 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 |
|---|---|---|---|
| LPN | Accessories, Soft Lens Products | FDA class 2 | Ophthalmic |
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