510(k) K781476
K781476 is an FDA 510(k) premarket notification submitted by Life-Tech Instruments, Inc. for the device "MULAR GOLD LEAF ELECTRODE MODEL 7501". The FDA issued a decision of Substantially Equivalent on November 15, 1978. The device falls under product code HLZ (Electrode, Corneal), a Class II device regulated under 21 CFR 886.1220. Life-Tech Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 1978
- Date Received
- August 28, 1978
- 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