TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR

Syringe, Antistick

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Surguard 2 Safety Needle Or Similar.

Pre-market Notification Details

• Device ID: K051865
• 510k Number: K051865
• Device Name: TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR
• Classification: Syringe, Antistick
• Applicant: TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921
• Contact: Barbara Smith
• Correspondent: Barbara Smith; TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921
• Product Code: MEG
• CFR Regulation Number: 880.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-07-11
• Decision Date: 2005-09-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
54806017506990	K051865	000
30612479178589	K051865	000
30612479178497	K051865	000
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