ULTRACARE

Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)

JOBST INSTITUTE, INC.

The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Ultracare.

Pre-market Notification Details

• Device ID: K883633
• 510k Number: K883633
• Device Name: ULTRACARE
• Classification: Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
• Applicant: JOBST INSTITUTE, INC. BOX 653 Toledo, OH 43694
• Contact: Wetzel, C.m.
• Correspondent: Wetzel, C.m.; JOBST INSTITUTE, INC. BOX 653 Toledo, OH 43694
• Product Code: DWL
• CFR Regulation Number: 880.5780 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-08-25
• Decision Date: 1988-10-18