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FDA 510(k) Application Details - K150505
Device Classification Name
More FDA Info for this Device
510(K) Number
K150505
Device Name
Cellfina System
Applicant
ULTHERA, INC.
1840 S Stapley Dr Suite 200
Mesa, AZ 85204 US
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Contact
Suzon Lommel
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OUP
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More FDA Info for this Product Code
Date Received
02/25/2015
Decision Date
07/29/2015
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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