DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES

Electrosurgical, Cutting & Coagulation & Accessories

SHUYOU ELECTRIC MEDICAL SCIENCE CO., LTD.

The following data is part of a premarket notification filed by Shuyou Electric Medical Science Co., Ltd. with the FDA for Disposable Grounding Pad Series And Electrode Series.

Pre-market Notification Details

• Device ID: K091672
• 510k Number: K091672
• Device Name: DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: SHUYOU ELECTRIC MEDICAL SCIENCE CO., LTD. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 200030
• Contact: Diana Hong
• Correspondent: Diana Hong; SHUYOU ELECTRIC MEDICAL SCIENCE CO., LTD. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 200030
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-06-09
• Decision Date: 2009-12-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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