TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE

Needle, Hypodermic, Single Lumen

TSK LABORATORY, JAPAN

The following data is part of a premarket notification filed by Tsk Laboratory, Japan with the FDA for Tsk Sterijekt Premium Disposable Hypodermic Needle.

Pre-market Notification Details

Device IDK970370
510k NumberK970370
Device Name:TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant TSK LABORATORY, JAPAN 2-1-5, HIRAYANAGI-CHO Tochigi-shi, Tochigi-ken,  JP
ContactNorman S Johnson
CorrespondentNorman S Johnson
TSK LABORATORY, JAPAN 2-1-5, HIRAYANAGI-CHO Tochigi-shi, Tochigi-ken,  JP
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-31
Decision Date1997-04-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14571225314089 K970370 000
14571225315093 K970370 000
14571225315024 K970370 000
14571225314225 K970370 000
14571225314164 K970370 000
14571225317998 K970370 000
14571225317974 K970370 000
14580708061501 K970370 000
14580708061495 K970370 000
14580708061792 K970370 000
14580708061785 K970370 000
14571225315574 K970370 000
14571225315529 K970370 000
14571225314171 K970370 000
24580708061805 K970370 000
14580708063284 K970370 000
14571225315147 K970370 000
14571225317257 K970370 000
14571225314072 K970370 000
14571225317684 K970370 000
14571225317677 K970370 000
24571225317667 K970370 000
24571225317650 K970370 000
14571225317608 K970370 000
14571225317592 K970370 000
14571225317585 K970370 000
14571225315956 K970370 000
14571225315079 K970370 000
14571225317561 K970370 000
24571225317551 K970370 000
14571225317547 K970370 000
24571225317391 K970370 000
24571225317346 K970370 000
14580708063277 K970370 000
14580708063260 K970370 000
14571225315017 K970370 000
24571225314215 K970370 000
34571225314151 K970370 000
14571225317844 K970370 000
24571225317834 K970370 000
14571225317820 K970370 000
14571225317813 K970370 000
14571225317806 K970370 000
14571225317790 K970370 000
14571225317776 K970370 000
14571225314232 K970370 000
14571225314201 K970370 000
14571225314195 K970370 000
14571225314119 K970370 000
14571225314102 K970370 000
24571225315038 K970370 000
24571225315083 K970370 000
14580708063253 K970370 000
24571225317858 K970370 000
14571225317646 K970370 000
24571225317636 K970370 000
24571225315991 K970370 000
24580708062697 K970370 000
14571225316731 K970370 000
24571225315984 K970370 000
24571225315861 K970370 000
14571225315789 K970370 000
24571225315700 K970370 000
14571225315635 K970370 000
14571225315628 K970370 000
24571225315175 K970370 000
14571225315116 K970370 000
14571225317622 K970370 000
14571225314096 K970370 000
24571225316707 K970370 000
14571225315765 K970370 000
14571225315758 K970370 000
14571225315734 K970370 000
14571225315710 K970370 000
14571225315697 K970370 000
14571225315673 K970370 000
14571225315659 K970370 000
14571225315550 K970370 000
14571225315543 K970370 000
14571225315505 K970370 000
14571225315499 K970370 000
14571225315451 K970370 000
14571225315437 K970370 000
14571225315420 K970370 000
14571225315376 K970370 000
14571225315802 K970370 000
14571225315819 K970370 000
14571225316694 K970370 000
14571225316687 K970370 000
14571225316199 K970370 000
14571225316113 K970370 000
14571225316090 K970370 000
14571225316083 K970370 000
14571225316076 K970370 000
14571225315970 K970370 000
14571225315949 K970370 000
14571225315925 K970370 000
14571225315901 K970370 000
14571225315888 K970370 000
14571225315871 K970370 000
14571225315857 K970370 000
14571225315833 K970370 000
14571225315369 K970370 000
14571225315345 K970370 000
14571225314645 K970370 000
14571225314614 K970370 000
14571225314553 K970370 000
14571225314546 K970370 000
14571225314539 K970370 000
14571225314522 K970370 000
14571225314430 K970370 000
04571225314419 K970370 000
14571225314393 K970370 000
14571225314379 K970370 000
04571225314358 K970370 000
14571225314331 K970370 000
14571225314317 K970370 000
14571225314294 K970370 000
34571225313673 K970370 000
14571225314676 K970370 000
14571225314713 K970370 000
14571225315321 K970370 000
14571225315307 K970370 000
14571225315284 K970370 000
14571225315185 K970370 000
14571225315161 K970370 000
14571225314942 K970370 000
14571225314911 K970370 000
14571225314867 K970370 000
14571225314836 K970370 000
14571225314829 K970370 000
14571225314805 K970370 000
14571225314799 K970370 000
14571225314751 K970370 000
14571225314744 K970370 000
14571225314720 K970370 000
14571225317226 K970370 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.