SURE-LOK

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 Sure-lok.

Pre-market Notification Details

• Device ID: K021315
• 510k Number: K021315
• Device Name: SURE-LOK
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: VITAL SIGNS, INC. 11039 EAST LANSING CIRCLE Englewood, CO 80112
• Contact: Thomas W Dielmann
• Correspondent: Thomas W Dielmann; VITAL SIGNS, INC. 11039 EAST LANSING CIRCLE Englewood, CO 80112
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-04-25
• Decision Date: 2002-08-21
• Summary: summary