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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K182392
Device Name Frozen C
Applicant
B.M. Tech. Worldwide Co., Ltd.
#609, 808, 1001~1007, Jungang Lnduspia 5-Cha, 137,
Sagimakgol-Ro, Jungwon-Gu
Seongnam-Si,  KR 13202
Applicant Contact Jenny Cho
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
MLY  
Date Received09/04/2018
Decision Date 10/30/2018
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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