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FDA 510(k) Application Details - K163176
Device Classification Name
More FDA Info for this Device
510(K) Number
K163176
Device Name
Exilis XP II
Applicant
BTL Industries, Inc.
47 Loring Drive
Framingham, MA 01702 US
Other 510(k) Applications for this Company
Contact
David Chmel
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PBX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/14/2016
Decision Date
01/12/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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