CHILLBUSTER

System, Thermal Regulating

MICROTEK MEDICAL, INC.

The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Chillbuster.

Pre-market Notification Details

• Device ID: K022903
• 510k Number: K022903
• Device Name: CHILLBUSTER
• Classification: System, Thermal Regulating
• Applicant: MICROTEK MEDICAL, INC. 512 LEHMBERG RD. Columbus, MS 39702
• Contact: Thomas Bonner
• Correspondent: Thomas Bonner; MICROTEK MEDICAL, INC. 512 LEHMBERG RD. Columbus, MS 39702
• Product Code: DWJ
• CFR Regulation Number: 870.5900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-09-03
• Decision Date: 2002-11-27
• Summary: summary