ABLE CENTRAL VENOUS CATHETER

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD

The following data is part of a premarket notification filed by Foshan Nanhai Bai He Medical Technology Co., Ltd with the FDA for Able Central Venous Catheter.

Pre-market Notification Details

• Device ID: K070451
• 510k Number: K070451
• Device Name: ABLE CENTRAL VENOUS CATHETER
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD SUITE 8D, NO.19 LANE 999, ZHONG SHAN NAN ER ROAD Shanghai, CN 528200
• Contact: Diana Hong
• Correspondent: Diana Hong; FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD SUITE 8D, NO.19 LANE 999, ZHONG SHAN NAN ER ROAD Shanghai, CN 528200
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-02-15
• Decision Date: 2007-07-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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