510(k) K923167
K923167 is an FDA 510(k) premarket notification submitted by Nissel , Ltd. for the device "THE NISSEL ARTIFICIAL EYE". The FDA issued a decision of Substantially Equivalent on September 2, 1992. The device falls under product code HQH (Eye, Artificial, Non-Custom), a Class I device regulated under 21 CFR 886.3200. Nissel , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 1992
- Date Received
- June 29, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Eye, Artificial, Non-Custom
- Device Class
- Class I
- Regulation Number
- 886.3200
- Review Panel
- OP
- Submission Type