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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 K203135
Device Name Medline Vacu-line Suction Aspirator
Applicant
Medline Industries, Inc.
Three Lake Drive
Northfield,  IL  60093
Applicant Contact Kelsey Closen
Correspondent
Medline Industries, Inc.
Three Lake Drive
Northfield,  IL  60093
Correspondent Contact Kelsey Closen
Regulation Number878.4780
Classification Product Code
BTA  
Date Received10/19/2020
Decision Date 05/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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