510(k) K872747
K872747 is an FDA 510(k) premarket notification submitted by Innomed Corp. for the device "LASER CENTERING DEVICE". The FDA issued a decision of Substantially Equivalent on September 4, 1987. The device falls under product code HMR (Marker, Ocular), a Class I device regulated under 21 CFR 886.4570. Innomed Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 1987
- Date Received
- July 13, 1987
- 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