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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 K181667
Device Name Thoraguard System
Applicant
Centese, Inc.
3929 Harney St. Suite 3008
Omaha,  NE  68131
Applicant Contact Evan Luxon
Correspondent
Centese, Inc.
3929 Harney St. Suite 3008
Omaha,  NE  68131
Correspondent Contact Evan Luxon
Regulation Number878.4780
Classification Product Code
BTA  
Date Received06/25/2018
Decision Date 11/29/2018
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
Predetermined Change
Control Plan Authorized		 No
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