510(k) K181087
K181087 is an FDA 510(k) premarket notification submitted by Guilin Woodpecker Medical Instrument Co., Ltd. for the device "Apex Locator, DPEX III". The FDA issued a decision of Substantially Equivalent on December 18, 2018. The device falls under product code LQY (Locator, Root Apex), a Class U device. Guilin Woodpecker Medical Instrument Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2018
- Date Received
- April 25, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Root Apex
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type