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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 K141126
Device Name UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE
Applicant
UNISIS CORP.
1201 RICHARDSON DRIVE, SUITE 280
RICHARDSON,  TX  75080
Applicant Contact DIANE RUTHERFORD
Correspondent
UNISIS CORP.
1201 RICHARDSON DRIVE, SUITE 280
RICHARDSON,  TX  75080
Correspondent Contact DIANE RUTHERFORD
Regulation Number868.5150
Classification Product Code
BSP  
Date Received05/01/2014
Decision Date 10/31/2014
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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