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510(k) K222856

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2022
Date Received
September 21, 2022
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.

  • K231063 — SOMAVAC® 100 Sustained Vacuum System (May 12, 2023)
  • K180606 — SOMAVAC Device (May 31, 2018)

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  • K241852 — Nasal Aspirator (NS 13) (December 31, 2024)
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  • K233901 — Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009 (March 20, 2024)