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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Compound, Powered)
510(k) Number K071931
Device Name CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
Applicant
Codman & Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Applicant Contact EMILY E VALERIO
Correspondent
Codman & Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Correspondent Contact EMILY E VALERIO
Regulation Number882.4305
Classification Product Code
HBF  
Date Received07/13/2007
Decision Date 10/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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