BIOBANDS

Device, Acupressure

BIOBANDS DISTRIBUTORS, INC.

The following data is part of a premarket notification filed by Biobands Distributors, Inc. with the FDA for Biobands.

Pre-market Notification Details

• Device ID: K051397
• 510k Number: K051397
• Device Name: BIOBANDS
• Classification: Device, Acupressure
• Applicant: BIOBANDS DISTRIBUTORS, INC. 1050 CONNECTICUT AVENUE NW Washington, DC 20036
• Contact: James H Hartten
• Correspondent: James H Hartten; BIOBANDS DISTRIBUTORS, INC. 1050 CONNECTICUT AVENUE NW Washington, DC 20036
• Product Code: MVV
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-05-27
• Decision Date: 2005-09-16
• Summary: summary