SUPER DONUT

Bedding, Disposable, Medical

ALIMED, INC.

The following data is part of a premarket notification filed by Alimed, Inc. with the FDA for Super Donut.

Pre-market Notification Details

• Device ID: K822650
• 510k Number: K822650
• Device Name: SUPER DONUT
• Classification: Bedding, Disposable, Medical
• Applicant: ALIMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KME
• CFR Regulation Number: 880.6060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-09-02
• Decision Date: 1982-09-30