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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Headrest, Neurosurgical
510(k) Number K911918
Device Name SWIVEL HORSESHOE HEADREST
Applicant
Codman & Shurtleff, Inc.
41 PACELLA PARK DR.
RANDOLPH INDUSTRIAL PARK
RANDOLPH,  MA  02368 -1794
Applicant Contact THOMAS J COURAGE
Correspondent
Codman & Shurtleff, Inc.
41 PACELLA PARK DR.
RANDOLPH INDUSTRIAL PARK
RANDOLPH,  MA  02368 -1794
Correspondent Contact THOMAS J COURAGE
Regulation Number882.4440
Classification Product Code
HBM  
Date Received04/30/1991
Decision Date 07/17/1991
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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