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FDA 510(k) Application Details - K130225
Device Classification Name
Light Based Over The Counter Wrinkle Reduction
More FDA Info for this Device
510(K) Number
K130225
Device Name
Light Based Over The Counter Wrinkle Reduction
Applicant
SILVERBAY LLC, D/B/A QUASAR BIO-TECH
2424DEMPSTER DRIVE
CORALVILLE, IA 52241 US
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Contact
ROBERT WAGNER
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
OHS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/29/2013
Decision Date
07/11/2013
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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