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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 K182458
Device Name Longterm NPWT Foam Dressing Kit
Applicant
Zhejiang Longterm Medical Technology Co., Ltd.
# 493 N. Huancheng Rd., Mogan Mountain National
High-Tech District
Deqing,  CN 313200
Applicant Contact Claudia Zsang
Correspondent
Zhejiang Longterm Medical Technology Co., Ltd.
# 493 N. Huancheng Rd., Mogan Mountain National
High-Tech District
Deqing,  CN 313200
Correspondent Contact Claudia Zsang
Regulation Number878.4780
Classification Product Code
OMP  
Date Received09/10/2018
Decision Date 05/23/2019
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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