FDA 510(k) Application Details - K170709

Device Classification Name

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510(K) Number K170709
Device Name CURVE Laser System
Applicant YOLO Medical, Inc.
1959 152nd Street, Suite 245
Surrey v4a 9e3 CA
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Contact Robert Krznaric
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Regulation Number

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Classification Product Code OLI
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Date Received 03/08/2017
Decision Date 06/06/2017
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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