ELVAREX

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

JOBST A BEIERSDORF CO.

The following data is part of a premarket notification filed by Jobst A Beiersdorf Co. with the FDA for Elvarex.

Pre-market Notification Details

• Device ID: K963573
• 510k Number: K963573
• Device Name: ELVAREX
• Classification: Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
• Applicant: JOBST A BEIERSDORF CO. 5825 CARNEGIE BLVD. Charlotte, NC 28209 -4633
• Contact: Angelo R Pereira
• Correspondent: Angelo R Pereira; JOBST A BEIERSDORF CO. 5825 CARNEGIE BLVD. Charlotte, NC 28209 -4633
• Product Code: DWL
• CFR Regulation Number: 880.5780 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-09-05
• Decision Date: 1996-10-16
• Summary: summary