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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 K110194
Device Name MEDLINE EPIDURAL AND SPINAL NEEDLES
Applicant
MEDLINE, INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Applicant Contact MATT CLAUSEN
Correspondent
MEDLINE, INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Correspondent Contact MATT CLAUSEN
Regulation Number868.5150
Classification Product Code
BSP  
Date Received01/24/2011
Decision Date 06/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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