510(k) K963043
K963043 is an FDA 510(k) premarket notification submitted by Corin USA for the device "ENDOSPOT". The FDA issued a decision of Substantially Equivalent on September 20, 1996. The device falls under product code FCW (Light Source, Fiberoptic, Routine), a Class II device regulated under 21 CFR 876.1500. Corin USA has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 1996
- Date Received
- August 5, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Source, Fiberoptic, Routine
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type