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FDA 510(k) Application Details - K193363
Device Classification Name
System, Suction, Lipoplasty
More FDA Info for this Device
510(K) Number
K193363
Device Name
System, Suction, Lipoplasty
Applicant
Puregraft LLC
420 Stevens Avenue, Suite 220
Solana Beach, CA 92075 US
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Contact
Olivia Kim
Other 510(k) Applications for this Contact
Regulation Number
878.5040
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Classification Product Code
MUU
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More FDA Info for this Product Code
Date Received
12/04/2019
Decision Date
04/14/2020
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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