THERMAPAD

Bedding, Disposable, Medical

AVAIL-SOUTHWEST DIVISION

The following data is part of a premarket notification filed by Avail-southwest Division with the FDA for Thermapad.

Pre-market Notification Details

• Device ID: K864158
• 510k Number: K864158
• Device Name: THERMAPAD
• Classification: Bedding, Disposable, Medical
• Applicant: AVAIL-SOUTHWEST DIVISION 4201 B KELLWAY CIRCLE Dallas, TX 75244
• Contact: Ken W Knezek
• Correspondent: Ken W Knezek; AVAIL-SOUTHWEST DIVISION 4201 B KELLWAY CIRCLE Dallas, TX 75244
• Product Code: KME
• CFR Regulation Number: 880.6060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-10-23
• Decision Date: 1987-03-02