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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K231063
Device Name SOMAVAC® 100 Sustained Vacuum System
Applicant
Somavac Medical Solutions, Inc.
3144 Stage Post Rd. Unit 101
Bartlett,  TN  38133
Applicant Contact Phil Ryan
Correspondent
MRC Global, LLC
9085 E. Mineral Cir
Suite 110
Centennial,  CO  80112
Correspondent Contact Dawn Norman
Regulation Number878.4780
Classification Product Code
BTA  
Date Received04/14/2023
Decision Date 05/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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