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FDA 510(k) Application Details - K182054
Device Classification Name
Expander, Skin, Inflatable
More FDA Info for this Device
510(K) Number
K182054
Device Name
Expander, Skin, Inflatable
Applicant
Allergan
2525 Dupont Drive
Irvine, CA 92612 US
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Contact
Melissa Pathmajeyan
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LCJ
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More FDA Info for this Product Code
Date Received
07/31/2018
Decision Date
08/29/2018
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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