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510(k) K231063

SOMAVAC® 100 Sustained Vacuum System by Somavac Medical Solutions, Inc. — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2023
Date Received
April 14, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by Somavac Medical Solutions, Inc.

  • K222856 — SOMAVAC 100 Sustained Vacuum System (October 19, 2022)
  • K180606 — SOMAVAC Device (May 31, 2018)

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