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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K120274
Device Name DELTAMAXX 18 MICROCOIL SYSTEM
Applicant
Codman and Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Applicant Contact KIM FONDA
Correspondent
Codman and Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Correspondent Contact KIM FONDA
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received01/30/2012
Decision Date 03/02/2012
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
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