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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K142553
Device Name UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle
Applicant
UNISIS CORP.
2675-1, NISHIKATA
KOSHIGAYA-SHI,  JP 3430822
Applicant Contact Tadashi Yasuda
Correspondent
KEN BLOCK CONSULTING
1201 RICHARDSON DRIVE
SUITE 280
RICHARDSON,  TX  75080 -4403
Correspondent Contact Diane Rutherford
Regulation Number868.5150
Classification Product Code
BSP  
Date Received09/10/2014
Decision Date 01/14/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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