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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K965017
Device Name REGIONAL ANESTHESIA TRAYS
Applicant
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
15 KIT ST.
KEENE,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
15 KIT ST.
KEENE,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received12/16/1996
Decision Date 03/14/1997
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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