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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Breast Implant Suction Retrieval Device
510(k) Number K252438
Device Name Explant Express
Applicant
Applied Medical Technology, Inc.
8006 Katherine Blvd.
Brecksville,  OH  44141
Applicant Contact Steven Curtis
Correspondent
Applied Medical Technology, Inc.
8006 Katherine Blvd.
Brecksville,  OH  44141
Correspondent Contact Steven Curtis
Classification Product Code
QVS  
Date Received08/01/2025
Decision Date 02/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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