510(k) K870154
K870154 is an FDA 510(k) premarket notification submitted by Porex Medical for the device "POREX(TM) TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on February 24, 1987. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Porex Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 1987
- Date Received
- January 13, 1987
- 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