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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 Dr.
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
Predetermined Change
Control Plan Authorized		 No
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