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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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