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 IDK221126
510k NumberK221126
Device Name:Unistik® 3, Sterile Single-use Safety Lancets; Unistik® 3 Value, Sterile Single-use Safety Lancets; Abbott SF Sterile Single-use Safety Lancets
ClassificationSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Applicant Owen Mumford Ltd Brook Hill Woodstock,  GB OX20 1TU
ContactDarren Mansell
CorrespondentDarren Mansell
Owen Mumford Ltd Brook Hill Woodstock,  GB OX20 1TU
Product CodeFMK  
CFR Regulation Number878.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-18
Decision Date2022-08-12

Trademark Results [Unistik]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UNISTIK
UNISTIK
81001544 1001544 Dead/Cancelled
Union Paper Co., Inc.
0000-00-00
UNISTIK
UNISTIK
77222140 3588007 Dead/Cancelled
Suchin Ratanasiriwilai
2007-07-05
UNISTIK
UNISTIK
74454553 1905529 Live/Registered
Owen Mumford Limited
1993-11-05
UNISTIK
UNISTIK
73361188 1232779 Dead/Cancelled
Babcock & Wilcox Company, The
1982-04-23

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