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FDA 510(k) Application Details - K161176
Device Classification Name
Expander, Skin, Inflatable
More FDA Info for this Device
510(K) Number
K161176
Device Name
Expander, Skin, Inflatable
Applicant
MENTOR WORLDWIDE LLC
33 TECHNOLOGY DRIVE
IRVINE, CA 92618 US
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Contact
LAURA C. VELLUCCI
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
04/26/2016
Decision Date
05/23/2016
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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