510(k) K955510
K955510 is an FDA 510(k) premarket notification submitted by Products For Medicine for the device "X6000D SILENT SUN LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on January 31, 1996. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Products For Medicine has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1996
- Date Received
- December 4, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Fiberoptic
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type