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510(k) K223603

Reflow System Mini and ReFlow Mini Flusher by Anuncia Medical, Inc. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2022
Date Received
December 2, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

Other clearances by Anuncia Medical, Inc.

  • K221918 — ReFlow System Mini (September 29, 2022)

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