BODYGUARD

Needle, Hypodermic, Single Lumen

VITAL SIGNS, INC.

The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Bodyguard.

Pre-market Notification Details

• Device ID: K000441
• 510k Number: K000441
• Device Name: BODYGUARD
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512
• Contact: Anthony Martino
• Correspondent: Anthony Martino; VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-02-10
• Decision Date: 2000-04-11