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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K180725
Device Name Aspire Introducer Needle
Applicant
Aspire Bariatrics, Inc.
3200 Horizon Dr.
Suite 100
King Of Prussia,  PA  19406
Applicant Contact Monica Ferrante
Correspondent
Aspire Bariatrics, Inc.
3200 Horizon Dr.
Suite 100
King Of Prussia,  PA  19406
Correspondent Contact Monica Ferrante
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/20/2018
Decision Date 07/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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