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 ID: K970370
• 510k Number: K970370
• Device Name: TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: TSK LABORATORY, JAPAN 2-1-5, HIRAYANAGI-CHO Tochigi-shi, Tochigi-ken, JP
• Contact: Norman S Johnson
• Correspondent: Norman S Johnson; TSK LABORATORY, JAPAN 2-1-5, HIRAYANAGI-CHO Tochigi-shi, Tochigi-ken, JP
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-01-31
• Decision Date: 1997-04-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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