510(k) K822828
K822828 is an FDA 510(k) premarket notification submitted by Safeway Products, Inc. for the device "SOFT LENS THERMAL DISINFECTING UNIT, A-C". The FDA issued a decision of Substantially Equivalent on October 29, 1982. The device falls under product code HRD (Sterilizer, Soft-Lens, Thermal, Ac-Powered), a Class II device regulated under 21 CFR 886.5928. Safeway Products, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 1982
- Date Received
- September 21, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Soft-Lens, Thermal, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type