510(k) K870754

MCGHAN TISSUE EXPANDER FILL SYSTEM by Mcghan Medical Corp. — Product Code LCJ

K870754 is an FDA 510(k) premarket notification submitted by Mcghan Medical Corp. for the device "MCGHAN TISSUE EXPANDER FILL SYSTEM". The FDA issued a decision of Substantially Equivalent on March 31, 1987. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Mcghan Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1987
Date Received
February 26, 1987
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