510(k) K112534
K112534 is an FDA 510(k) premarket notification submitted by Lifecell Corp. for the device "LIFECELL TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on August 10, 2012. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Lifecell Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2012
- Date Received
- September 1, 2011
- 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