510(k) K070303
K070303 is an FDA 510(k) premarket notification submitted by Specialty Surgical Products for the device "SILICONE TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on June 22, 2007. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Specialty Surgical Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 2007
- Date Received
- January 31, 2007
- 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