YI XIN STERILE SYRINGE FOR SINGLE USE

Syringe, Piston

JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP

The following data is part of a premarket notification filed by Jiangxi Sanxin (eversincere) Medical Devices Group with the FDA for Yi Xin Sterile Syringe For Single Use.

Pre-market Notification Details

• Device ID: K050999
• 510k Number: K050999
• Device Name: YI XIN STERILE SYRINGE FOR SINGLE USE
• Classification: Syringe, Piston
• Applicant: JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP SHANJIANG ROAD Nanchang, Jiangxi, CN 330204
• Contact: Yun Yuan Gao
• Correspondent: Yun Yuan Gao; JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP SHANJIANG ROAD Nanchang, Jiangxi, CN 330204
• Product Code: FMF
• CFR Regulation Number: 880.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-04-20
• Decision Date: 2005-09-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20858835007053	K050999	000
B031AH01L01	K050999	000
B031AHS3013RN2	K050999	000
B031AHS2738RN2	K050999	000
B031AHS2538RN2	K050999	000
B031AHS2525RN2	K050999	000
B031AHS2516RN2	K050999	000
B031AHS2325RN2	K050999	000
B031AHS2238RN2	K050999	000
B031AHS2225RN2	K050999	000
B031AHS2219RN2	K050999	000
B031AH01L251601	K050999	000
B031AH03L233801	K050999	000
20858835007046	K050999	000
20858835007039	K050999	000
20858835007022	K050999	000
20858835007015	K050999	000
20858835007008	K050999	000
B031AH03M30131	K050999	000
B031AHS2714RN01	K050999	000
B031AHS2713RN01	K050999	000
B031AH10M301301	K050999	000
B031AH05M310301	K050999	000
B031AHS2125RN2	K050999	000
B031AHS2038RN2	K050999	000
B031AH03L23252	K050999	000
B031AH03L22382	K050999	000
B031AH03L22252	K050999	000
B031AH03L22192	K050999	000
B031AH03L21252	K050999	000
B031AH03L20382	K050999	000
B031AH03L20252	K050999	000
B031AH03L18382	K050999	000
B031AH03L18252	K050999	000
B031AH01T27132	K050999	000
B031AH03L25162	K050999	000
B031AH03L25252	K050999	000
B031AHS2025RN2	K050999	000
B031AHS1838RN2	K050999	000
B031AHS1825RN2	K050999	000
B031AH10M2913402	K050999	000
B031AH10M29132	K050999	000
B031AH05M2913402	K050999	000
B031AH05M29132	K050999	000
B031AH03S22192	K050999	000
B031AH03L27382	K050999	000
B031AH03L25382	K050999	000
B031AH01T25162	K050999	000
20858835007954	K050999	000
B031AH60S2	K050999	000
B031AH01T0	K050999	000
16945060500163	K050999	000
16945060500156	K050999	000
16945060500149	K050999	000
16945060500132	K050999	000
16945060500125	K050999	000
16945060500118	K050999	000
16945060500101	K050999	000
16945060500095	K050999	000
16945060500088	K050999	000
B031AH03L2	K050999	000
B031AH03S2	K050999	000
B031AH60L2	K050999	000
B031AH60C2	K050999	000
B031AH30S2	K050999	000
B031AH30L2	K050999	000
B031AH20S2	K050999	000
B031AH20L2	K050999	000
B031AH10S2	K050999	000
B031AH10L2	K050999	000
B031AH05S2	K050999	000
B031AH05L2	K050999	000
16945060500071	K050999	000
16945060500064	K050999	000
16945060501092	K050999	000
16945060501085	K050999	000
16945060501078	K050999	000
16945060501061	K050999	000
16945060501054	K050999	000
16945060501047	K050999	000
16945060501030	K050999	000
16945060501023	K050999	000
16945060501016	K050999	000
20858835007978	K050999	000
16945060501108	K050999	000
16945060501115	K050999	000
16945060500057	K050999	000
16945060500040	K050999	000
16945060500033	K050999	000
16945060500026	K050999	000
16945060500019	K050999	000
16945060501160	K050999	000
16945060501153	K050999	000
16945060501146	K050999	000
16945060501139	K050999	000
16945060501122	K050999	000
20858835007961	K050999	000