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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K243721
Device Name Self Sealing Sterilization Pouches
Applicant
Wellmed Dental Medical Supply Co., Ltd.
301 Zhongxin Science And Technology Bldg., #64,
Xin’An 2nd Rd., Baoan District
Shenzhen,  CN
Applicant Contact Renxian Tang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Luna Hu
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
JOJ  
Date Received12/03/2024
Decision Date 04/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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