TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE

Needle, Hypodermic, Single Lumen

TERUMO (PHILIPPINES) CORPORATION

The following data is part of a premarket notification filed by Terumo (philippines) Corporation with the FDA for Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe With Safety Needle.

Pre-market Notification Details

• Device ID: K113422
• 510k Number: K113422
• Device Name: TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: TERUMO (PHILIPPINES) CORPORATION #124 EAST MAIN AVE. LAGUNA TECHNOPARK Binan, Laguna, PH 4026
• Contact: Sandi Hartka
• Correspondent: Sandi Hartka; TERUMO (PHILIPPINES) CORPORATION #124 EAST MAIN AVE. LAGUNA TECHNOPARK Binan, Laguna, PH 4026
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-11-21
• Decision Date: 2012-03-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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