SEROJET

Injector, Fluid, Non-electrically Powered

BIOJECT, INC.

The following data is part of a premarket notification filed by Bioject, Inc. with the FDA for Serojet.

Pre-market Notification Details

• Device ID: K003908
• 510k Number: K003908
• Device Name: SEROJET
• Classification: Injector, Fluid, Non-electrically Powered
• Applicant: BIOJECT, INC. 7620 S.W. BRIDGEPORT RD. Portland, OR 97224
• Contact: Nancy J Gertlar
• Correspondent: Nancy J Gertlar; BIOJECT, INC. 7620 S.W. BRIDGEPORT RD. Portland, OR 97224
• Product Code: KZE
• CFR Regulation Number: 880.5430 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-12-19
• Decision Date: 2001-03-08