510(k) K925606
K925606 is an FDA 510(k) premarket notification submitted by Chiron Vision Corp. for the device "OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS". The FDA issued a decision of Substantially Equivalent on August 29, 1994. The device falls under product code HMR (Marker, Ocular), a Class I device regulated under 21 CFR 886.4570. Chiron Vision Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 1994
- Date Received
- November 5, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Ocular
- Device Class
- Class I
- Regulation Number
- 886.4570
- Review Panel
- OP
- Submission Type