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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
Original Applicant
82 sanderson avenue
lynn,  MA  01902
Original Contact erik piasio
Regulation Number882.4700
Classification Product Code
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