HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE

Needle, Hypodermic, Single Lumen

SMITHS MEDICAL ASD, INC.

The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Hypodermic Needle-pro Edge Safety Device, Hypodermic Needle-pro Edge Safety Device With Syringe.

Pre-market Notification Details

• Device ID: K071785
• 510k Number: K071785
• Device Name: HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431
• Contact: Brian Farias
• Correspondent: Brian Farias; SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-07-02
• Decision Date: 2007-08-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
55019517065679	K071785	000
15019517065947	K071785	000
10351688075505	K071785	000
30351688075523	K071785	000
10351688066558	K071785	000
10351688069788	K071785	000
30351688069799	K071785	000
30351688069805	K071785	000
10351688069818	K071785	000
30351688070832	K071785	000
30351688070849	K071785	000
35019517065866	K071785	000
55019517065853	K071785	000
35019517065842	K071785	000
35019517065682	K071785	000
55019517065709	K071785	000
35019517065729	K071785	000
55019517065730	K071785	000
35019517065743	K071785	000
35019517065750	K071785	000
55019517065778	K071785	000
35019517065804	K071785	000
35019517065828	K071785	000
35019517065835	K071785	000
30351688070856	K071785	000
30351688070863	K071785	000
30351688071006	K071785	000
10351688071019	K071785	000
10351688071026	K071785	000
50351688072953	K071785	000
30351688072966	K071785	000
30351688072973	K071785	000
30351688072980	K071785	000
30351688072997	K071785	000
30351688073000	K071785	000
50351688073011	K071785	000
10351688070999	K071785	000
10351688070982	K071785	000
10351688070975	K071785	000
30351688070870	K071785	000
30351688070887	K071785	000
10351688070890	K071785	000
30351688070900	K071785	000
10351688070913	K071785	000
10351688070920	K071785	000
10351688070937	K071785	000
30351688070948	K071785	000
10351688070951	K071785	000
10351688070968	K071785	000
30351688073598	K071785	000