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FDA 510(k) Application Details - K150777
Device Classification Name
Expander, Skin, Inflatable
More FDA Info for this Device
510(K) Number
K150777
Device Name
Expander, Skin, Inflatable
Applicant
MENTOR WORLDWIDE LLC
201 MENTOR DRIVE
SANTA BARBARA, CA 93111 US
Other 510(k) Applications for this Company
Contact
Manchi Cheung
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LCJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/25/2015
Decision Date
04/24/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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