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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, conduction, anesthetic
510(k) Number K051524
Device Name LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216
Applicant
SMITHS MEDICAL ASD, INC.
10 BOWMAN DRIVE
KEENE,  NH  03431
Applicant Contact CYNTHIA ENGELHARDT
Correspondent
SMITHS MEDICAL ASD, INC.
10 BOWMAN DRIVE
KEENE,  NH  03431
Correspondent Contact CYNTHIA ENGELHARDT
Regulation Number868.5120
Classification Product Code
BSO  
Date Received06/08/2005
Decision Date 07/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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