510(k) K884746
K884746 is an FDA 510(k) premarket notification submitted by Medical Engineering Corp. for the device "SURGITEK FLAT T-SPAN". The FDA issued a decision of Substantially Equivalent on August 10, 1989. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Medical Engineering Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 1989
- Date Received
- November 14, 1988
- 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