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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 K182184
Device Name Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
Applicant
Mdk (Shanghai) Medical Packing Co., Ltd.
# 233 Fengijan Rd., Fengcheng Town, Fengxian District
Shanghai,  CN 201409
Applicant Contact Gong Yaoren
Correspondent
Mdk (Shanghai) Medical Packing Co., Ltd.
# 233 Fengijan Rd., Fengcheng Town, Fengxian District
Shanghai,  CN 201409
Correspondent Contact Ray Wang
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
JOJ  
Date Received08/13/2018
Decision Date 10/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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