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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 K253199
Device Name CURASYS 2 (EMDN0003)
Applicant
CG Bio Co., Ltd.
1, Sangwon 12-Gil, Seongdong-Gu
Seoul,  KR 04791
Applicant Contact Youngwook Moon
Correspondent
CG Bio Co., Ltd.
1, Sangwon 12-Gil, Seongdong-Gu
Seoul,  KR 04791
Correspondent Contact Youngwook Moon
Regulation Number878.4780
Classification Product Code
OMP  
Date Received09/26/2025
Decision Date 06/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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