FDA 510(k) Application Details - K150720

Device Classification Name

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510(K) Number K150720
Device Name XP3000
Applicant BTL Industries, Inc.
47 Loring Drive
Framingham, MA 01702 US
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Contact Jan Zarsky
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Regulation Number

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Classification Product Code PBX
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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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