510(k) K844409
K844409 is an FDA 510(k) premarket notification submitted by Sauquoit Industries, Inc. for the device "DTL ELECTRODE". The FDA issued a decision of Substantially Equivalent on February 14, 1985. The device falls under product code HLZ (Electrode, Corneal), a Class II device regulated under 21 CFR 886.1220.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 1985
- Date Received
- November 14, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Corneal
- Device Class
- Class II
- Regulation Number
- 886.1220
- Review Panel
- OP
- Submission Type