MEDICOOL

Pack, Hot Or Cold, Water Circulating

MICROMEDIC SYSTEMS

The following data is part of a premarket notification filed by Micromedic Systems with the FDA for Medicool.

Pre-market Notification Details

• Device ID: K923643
• 510k Number: K923643
• Device Name: MEDICOOL
• Classification: Pack, Hot Or Cold, Water Circulating
• Applicant: MICROMEDIC SYSTEMS 3689 MANDO COURT Coleman, MI 48618
• Contact: Tomas E Dunn
• Correspondent: Tomas E Dunn; MICROMEDIC SYSTEMS 3689 MANDO COURT Coleman, MI 48618
• Product Code: ILO
• CFR Regulation Number: 890.5720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-07-21
• Decision Date: 1993-03-31