510(k) K061690
K061690 is an FDA 510(k) premarket notification submitted by Gulf Medical Fiberoptics for the device "SURGICAL HEADLIGHT". The FDA issued a decision of Substantially Equivalent on September 15, 2006. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Gulf Medical Fiberoptics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 15, 2006
- Date Received
- June 15, 2006
- 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