510(k) K865056

CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER by Cox-Uphuff Intl. — Product Code LCJ

K865056 is an FDA 510(k) premarket notification submitted by Cox-Uphuff Intl. for the device "CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on May 22, 1987. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Cox-Uphuff Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1987
Date Received
December 24, 1986
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