Frozen C

Unit, Cryosurgical, Accessories

B.M. Tech. Worldwide Co., Ltd.

The following data is part of a premarket notification filed by B.m. Tech. Worldwide Co., Ltd. with the FDA for Frozen C.

Pre-market Notification Details

• Device ID: K182392
• 510k Number: K182392
• Device Name: Frozen C
• Classification: Unit, Cryosurgical, Accessories
• Applicant: B.M. Tech. Worldwide Co., Ltd. #609, 808, 1001~1007, Jungang Lnduspia 5-cha, 137, Sagimakgol-ro, Jungwon-gu Seongnam-si, KR 13202
• Contact: Jenny Cho
• Correspondent: Dave Kim; MTech Group 8310 Buffalo Speedway Houston, TX 77025
• Product Code: GEH
• CFR Regulation Number: 878.4350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-09-04
• Decision Date: 2018-10-30
• Summary: summary