510(k) K131692
K131692 is an FDA 510(k) premarket notification submitted by Marz Medical, Inc. for the device "BLOSSOM SALINE DELIVERY ASSIST DEVICE". The FDA issued a decision of Substantially Equivalent on July 10, 2014. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2014
- Date Received
- June 10, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tissue Expander And Accessories
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type