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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instruments, surgical, cardiovascular
510(k) Number K761161
Device Name 67-8006 DARLING-LINTON AORTIC TOURN.
Applicant
Codman & Shurtleff, Inc.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
Codman & Shurtleff, Inc.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.4500
Classification Product Code
DWS  
Date Received11/29/1976
Decision Date 12/06/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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