510(k) K903448

SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER by Medical Engineering Corp. — Product Code LCJ

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