510(k) K903448
K903448 is an FDA 510(k) premarket notification submitted by Medical Engineering Corp. for the device "SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on January 14, 1991. 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
- January 14, 1991
- Date Received
- July 31, 1990
- 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