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FDA 510(k) Application Details - K143354
Device Classification Name
Expander, Skin, Inflatable
More FDA Info for this Device
510(K) Number
K143354
Device Name
Expander, Skin, Inflatable
Applicant
ALLERGAN, INC.
2525 DUPONT DRIVE
IRVINE, CA 92623-9534 US
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Contact
Bruce Krattenmaker
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
11/24/2014
Decision Date
08/20/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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