X-CUBE

Controller, Foot, Handpiece And Cord

SAESHIN PRECISION CO., LTD.

The following data is part of a premarket notification filed by Saeshin Precision Co., Ltd. with the FDA for X-cube.

Pre-market Notification Details

• Device ID: K092758
• 510k Number: K092758
• Device Name: X-CUBE
• Classification: Controller, Foot, Handpiece And Cord
• Applicant: SAESHIN PRECISION CO., LTD. #93-15, PAHO-DONG, DALSEO-GU Daegu, KR 704-220
• Contact: Y.s. Lee
• Correspondent: Marc M Mouser; UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526
• Product Code: EBW
• CFR Regulation Number: 872.4200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2009-09-09
• Decision Date: 2009-09-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08809260471054	K092758	000
08809260470835	K092758	000
08809260470828	K092758	000
08809260470811	K092758	000
08809260470804	K092758	000
08809260470798	K092758	000
08809260470781	K092758	000
08809260470309	K092758	000
08809260470293	K092758	000
08809260470842	K092758	000
08809260470859	K092758	000
08809260470866	K092758	000
08809260471047	K092758	000
08809260471030	K092758	000
08809260471023	K092758	000
08809260471016	K092758	000
08809260471009	K092758	000
08809260470897	K092758	000
08809260470880	K092758	000
08809260470873	K092758	000
08809260470286	K092758	000