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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K254019
Device Name Wound Geni NPWT System
Applicant
Bechtel Medical, Inc.
174 Bechtel Rd.
Collegeville,  PA  19426
Applicant Contact John Gvodas
Correspondent
Bechtel Medical, Inc.
174 Bechtel Rd.
Collegeville,  PA  19426
Correspondent Contact Rebecca Monaghan
Regulation Number878.4780
Classification Product Code
OMP  
Date Received12/15/2025
Decision Date 05/04/2026
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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