FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOFT LENS THERMAL DISINFECTING UNIT, A-C
K Number: K822828
·
Decision Oct 29, 1982
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
3
Review Days
38
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Basic Information
- Device Name
- SOFT LENS THERMAL DISINFECTING UNIT, A-C
- K Number
- K822828
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Safeway Products, Inc.
- Date Received
- September 21, 1982
- Decision Date
- October 29, 1982
- Product Code
- HRD
- 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 |
|---|---|---|---|
| HRD | Sterilizer, Soft-Lens, Thermal, Ac-Powered | FDA class 2 | Ophthalmic |