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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Paddie
510(k) Number K112598
Device Name AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
Applicant
AMERICAN SURGICAL COMPANY, LLC
82 SANDERSON AVENUE
LYNN,  MA  01902
Applicant Contact MICHAEL ALOUANE
Correspondent
AMERICAN SURGICAL COMPANY, LLC
82 SANDERSON AVENUE
LYNN,  MA  01902
Correspondent Contact MICHAEL ALOUANE
Regulation Number882.4700
Classification Product Code
HBA  
Date Received09/07/2011
Decision Date 06/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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