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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 K121822
Device Name DELICOT
Applicant
American Surgical Company, LLC
82 Sanderson Ave.
Lynn,  MA  01902
Applicant Contact ERIK PIASIO
Correspondent
American Surgical Company, LLC
82 Sanderson Ave.
Lynn,  MA  01902
Correspondent Contact ERIK PIASIO
Regulation Number882.4700
Classification Product Code
HBA  
Date Received06/21/2012
Decision Date 09/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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