510(k) K111524
K111524 is an FDA 510(k) premarket notification submitted by Marine Polymer Technologies, Inc. for the device "MP 719". The FDA issued a decision of Substantially Equivalent on July 22, 2011. The device falls under product code MTJ (Wax, Bone), a Class U device. Marine Polymer Technologies, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2011
- Date Received
- June 2, 2011
- 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