Immucise

Syringe, Piston

Terumo Corporation

The following data is part of a premarket notification filed by Terumo Corporation with the FDA for Immucise.

Pre-market Notification Details

• Device ID: K190427
• 510k Number: K190427
• Device Name: Immucise
• Classification: Syringe, Piston
• Applicant: Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-ku, JP 151-0072
• Contact: Rudima L Jackson
• Correspondent: Rudima L. Jackson; Terumo Medical Corporation 265 Davidson Ave Suite 320 Somerset, NJ 08873
• Product Code: FMF
• CFR Regulation Number: 880.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-02-22
• Decision Date: 2019-07-18