510(k) K904962
K904962 is an FDA 510(k) premarket notification submitted by Midwest Eye Laboratories, Inc. for the device "EYE ARTIFICIAL CUSTOM". The FDA issued a decision of Substantially Equivalent on August 30, 1991. The device falls under product code HQH (Eye, Artificial, Non-Custom), a Class I device regulated under 21 CFR 886.3200. Midwest Eye Laboratories, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 1991
- Date Received
- November 5, 1990
- 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