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510(k) K970370

TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE by Tsk Laboratory, Japan — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1997
Date Received
January 31, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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