510(k) K946226
K946226 is an FDA 510(k) premarket notification submitted by Frank Tanaka, Ocularist, Inc. for the device "CUSTOM OCULAR PROSTHESIS". The FDA issued a decision of Substantially Equivalent on March 22, 1995. The device falls under product code HQH (Eye, Artificial, Non-Custom), a Class I device regulated under 21 CFR 886.3200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1995
- Date Received
- December 22, 1994
- 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