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FDA 510(k) Application Details - K150720
Device Classification Name
More FDA Info for this Device
510(K) Number
K150720
Device Name
XP3000
Applicant
BTL Industries, Inc.
47 Loring Drive
Framingham, MA 01702 US
Other 510(k) Applications for this Company
Contact
Jan Zarsky
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
03/19/2015
Decision Date
09/16/2015
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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