SOFT LENS THERMAL DISINFECTING UNIT, A-C
FDA 510(k) clearance K822828 · decided 1982-10-29
Clearance details
- K-number
- K822828
- Device name
- SOFT LENS THERMAL DISINFECTING UNIT, A-C
- Applicant
- Safeway Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-09-21
- Decision date
- 1982-10-29
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- HRD
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.