510(k) K200452
K200452 is an FDA 510(k) premarket notification submitted by M/s. Meril Endo Surgery Private Limited. for the device "Meril-Bonewax". The FDA issued a decision of Substantially Equivalent on March 27, 2023. The device falls under product code MTJ (Wax, Bone), a Class U device. M/s. Meril Endo Surgery Private Limited. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2023
- Date Received
- February 24, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wax, Bone
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type