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510(k) K092284

LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200 by Medical Device Resource Corp. — Product Code MUU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2009
Date Received
July 29, 2009
Clearance Type
Special
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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