510(k) K861535
K861535 is an FDA 510(k) premarket notification submitted by CooperVision, Inc. for the device "OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU". The FDA issued a decision of Substantially Equivalent on May 14, 1986. The device falls under product code HMR (Marker, Ocular), a Class I device regulated under 21 CFR 886.4570. CooperVision, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 1986
- Date Received
- April 24, 1986
- 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