REDOX

Sleeve, Limb, Compressible

KINETIC CONCEPTS, INC.

The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Redox.

Pre-market Notification Details

• Device ID: K953850
• 510k Number: K953850
• Device Name: REDOX
• Classification: Sleeve, Limb, Compressible
• Applicant: KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78216 -9508
• Contact: William H Quirk
• Correspondent: William H Quirk; KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78216 -9508
• Product Code: JOW
• CFR Regulation Number: 870.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-08-16
• Decision Date: 1996-03-04
• Summary: summary