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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 K924242
Device Name DISPOSABLE PERFORATOR
Applicant
Codman & Shurtleff, Inc.
41 PACELLA PARK DR.
RANDOLPH INDUSTRIAL PARK
RANDOLPH,  MA  02368 -1794
Applicant Contact CARLETON SOUTHHWORTH
Correspondent
Codman & Shurtleff, Inc.
41 PACELLA PARK DR.
RANDOLPH INDUSTRIAL PARK
RANDOLPH,  MA  02368 -1794
Correspondent Contact CARLETON SOUTHHWORTH
Regulation Number882.4305
Classification Product Code
HBF  
Date Received08/24/1992
Decision Date 07/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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