510(k) K080025
K080025 is an FDA 510(k) premarket notification submitted by Guilin Woodpecker Medical Instrument Co., Ltd. for the device "LED.L, LED.M, LED.G, LED.B". The FDA issued a decision of Substantially Equivalent on March 19, 2008. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Guilin Woodpecker Medical Instrument Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2008
- Date Received
- January 4, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Activator, Ultraviolet, For Polymerization
- Device Class
- Class II
- Regulation Number
- 872.6070
- Review Panel
- DE
- Submission Type