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FDA 510(k) Application Details - K182335
Device Classification Name
Expander, Skin, Inflatable
More FDA Info for this Device
510(K) Number
K182335
Device Name
Expander, Skin, Inflatable
Applicant
Mentor Worldwide LLC
33 Technology Drive
Irvine, CA 92618 US
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Contact
Martin Sprunck
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
08/28/2018
Decision Date
09/25/2018
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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