510(k) K913239
K913239 is an FDA 510(k) premarket notification submitted by Doran Instruments, Inc. for the device "GOLDLENS(TM)". The FDA issued a decision of Substantially Equivalent on January 31, 1992. The device falls under product code HLZ (Electrode, Corneal), a Class II device regulated under 21 CFR 886.1220. Doran Instruments, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1992
- Date Received
- July 22, 1991
- 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