510(k) K920037
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1992
- Date Received
- January 6, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Soft-Lens, Thermal, Battery-Powered
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type