510(k) K864184

MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN by Mcghan Medical Corp. — Product Code LCJ

K864184 is an FDA 510(k) premarket notification submitted by Mcghan Medical Corp. for the device "MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN". The FDA issued a decision of Substantially Equivalent on December 24, 1986. 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
December 24, 1986
Date Received
October 27, 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