ULTICARE DISPOSABLE PEN NEEDLES

Needle, Hypodermic, Single Lumen

ULTIMED, INC.

The following data is part of a premarket notification filed by Ultimed, Inc. with the FDA for Ulticare Disposable Pen Needles.

Pre-market Notification Details

• Device ID: K100812
• 510k Number: K100812
• Device Name: ULTICARE DISPOSABLE PEN NEEDLES
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: ULTIMED, INC. 5353 WAYZATA BOULEVARD SUITE 505 Minneapolis, MN 55416 -1334
• Contact: Mary Beth Henderson
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2010-03-23
• Decision Date: 2010-06-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30041415073785	K100812	000
20087701432624	K100812	000
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