TRUJECT

Needle, Hypodermic, Single Lumen

CLIVE CRAIG CO.

The following data is part of a premarket notification filed by Clive Craig Co. with the FDA for Truject.

Pre-market Notification Details

• Device ID: K945284
• 510k Number: K945284
• Device Name: TRUJECT
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: CLIVE CRAIG CO. 600 E HUENEME RD. Oxnard, CA 93033
• Contact: Paul Wittrock
• Correspondent: Paul Wittrock; CLIVE CRAIG CO. 600 E HUENEME RD. Oxnard, CA 93033
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-10-31
• Decision Date: 1994-12-29