510(k) K853014

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

K853014 is an FDA 510(k) premarket notification submitted by Mcghan Medical Corp. for the device "MCGHAN TISSUE EXPANDER FILL KIT". The FDA issued a decision of Substantially Equivalent on September 18, 1985. 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
September 18, 1985
Date Received
July 17, 1985
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