CLICKER

Injector, Fluid, Non-electrically Powered

BIOJECT, INC.

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

Pre-market Notification Details

• Device ID: K994384
• 510k Number: K994384
• Device Name: CLICKER
• Classification: Injector, Fluid, Non-electrically Powered
• Applicant: BIOJECT, INC. 7620 S.W. BRIDGEPORT RD. Portland, OR 97224
• Contact: Nancy Gertlar
• Correspondent: Nancy 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: 1999-12-28
• Decision Date: 2000-06-22
• Summary: summary