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510(k) K191564

Progenikine Concentrating System 25 mL System by Emcyte Corporation — Product Code MUU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2019
Date Received
June 13, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Suction, Lipoplasty
Device Class
Class II
Regulation Number
878.5040
Review Panel
SU
Submission Type

See Federal Register Notice at 86 FR 50887 “Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article” (FRN) (FDA-2021-N-0881).

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