ONETOUCH REVEAL

Accessories, Pump, Infusion

LIFESCAN, INC.

The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Onetouch Reveal.

Pre-market Notification Details

• Device ID: K132618
• 510k Number: K132618
• Device Name: ONETOUCH REVEAL
• Classification: Accessories, Pump, Infusion
• Applicant: LIFESCAN, INC. 965 CHESTERBROOK BOULEVARD Wayne, PA 19087
• Contact: Gabrielle Logan
• Correspondent: Gabrielle Logan; LIFESCAN, INC. 965 CHESTERBROOK BOULEVARD Wayne, PA 19087
• Product Code: MRZ
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-08-21
• Decision Date: 2013-12-16
• Summary: summary