COOL.CLICK

Injector, Fluid, Non-electrically Powered

BIOJECT, INC.

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

Pre-market Notification Details

• Device ID: K050734
• 510k Number: K050734
• Device Name: COOL.CLICK
• Classification: Injector, Fluid, Non-electrically Powered
• Applicant: BIOJECT, INC. 20245 S.W. 95TH AVE. Tualatin, OR 97062
• Contact: Melanie Talbert
• Correspondent: Melanie Talbert; BIOJECT, INC. 20245 S.W. 95TH AVE. Tualatin, OR 97062
• Product Code: KZE
• CFR Regulation Number: 880.5430 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-03-21
• Decision Date: 2005-06-03
• Summary: summary