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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, scalp
510(k) Number K894778
Device Name CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER
Applicant
Codman & Shurtleff, Inc.
41 PACELLA PARK DR.
RANDOLPH INDUSTRIAL PARK
RANDOLPH,  MA  02368 -1794
Applicant Contact G CLOUTIER
Correspondent
Codman & Shurtleff, Inc.
41 PACELLA PARK DR.
RANDOLPH INDUSTRIAL PARK
RANDOLPH,  MA  02368 -1794
Correspondent Contact G CLOUTIER
Regulation Number882.4150
Classification Product Code
HBO  
Date Received07/27/1989
Decision Date 12/06/1989
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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