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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K242758
Device Name Atrauman® Ag
Applicant
Hartmann USA, Inc.
481 Lakeshore Pkwy.
Rock Hill,  SC  29730
Applicant Contact Xiong Lee
Correspondent
Qserve Group US
350 S. Main St.
Doylestown,  PA  18901
Correspondent Contact Lorry Weaver
Classification Product Code
FRO  
Date Received09/12/2024
Decision Date 12/09/2024
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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