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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 K153459
Device Name TACVAC
Applicant
ATHENA GTX
5900 NW 86TH STREET, SUITE 300
JOHNSTON,  IA  50131
Applicant Contact SEAN MAHONEY
Correspondent
ATHENA GTX
5900 NW 86TH STREET, SUITE 300
JOHNSTON,  IA  50131
Correspondent Contact SEAN MAHONEY
Regulation Number878.4780
Classification Product Code
BTA  
Date Received12/01/2015
Decision Date 01/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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