Unistik® 3, Sterile Single-use Safety Lancets; Unistik® 3 Value, Sterile Single-use Safety Lancets; Abbott SF Sterile Single-use Safety Lancets

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Owen Mumford Ltd

The following data is part of a premarket notification filed by Owen Mumford Ltd with the FDA for Unistik® 3, Sterile Single-use Safety Lancets; Unistik® 3 Value, Sterile Single-use Safety Lancets; Abbott Sf Sterile Single-use Safety Lancets.

Pre-market Notification Details

• Device ID: K221126
• 510k Number: K221126
• Device Name: Unistik® 3, Sterile Single-use Safety Lancets; Unistik® 3 Value, Sterile Single-use Safety Lancets; Abbott SF Sterile Single-use Safety Lancets
• Classification: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
• Applicant: Owen Mumford Ltd Brook Hill Woodstock, GB OX20 1TU
• Contact: Darren Mansell
• Correspondent: Darren Mansell; Owen Mumford Ltd Brook Hill Woodstock, GB OX20 1TU
• Product Code: FMK
• CFR Regulation Number: 878.4850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-04-18
• Decision Date: 2022-08-12