Dermapose Access

System, Suction, Lipoplasty

Puregraft LLC

The following data is part of a premarket notification filed by Puregraft Llc with the FDA for Dermapose Access.

Pre-market Notification Details

Device IDK200168
510k NumberK200168
Device Name:Dermapose Access
ClassificationSystem, Suction, Lipoplasty
Applicant Puregraft LLC 420 Stevens Avenue, Suite 220 Solana Beach,  CA  92075
ContactOlivia Kim
CorrespondentOlivia Kim
Puregraft LLC 420 Stevens Avenue, Suite 220 Solana Beach,  CA  92075
Product CodeMUU  
CFR Regulation Number878.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-23
Decision Date2020-04-22

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