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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 K933721
Device Name EPIDURAL ANESTHESIA PROCEDURE TRAY, CUSTOM
Applicant
Neurodelivery Technology, Inc.
P.O. Box 548 Chiron Springs
Offices, Etna Rd.
Lebanon,  NH  03766
Applicant Contact DENNIS WM. COOMBS
Correspondent
Neurodelivery Technology, Inc.
P.O. Box 548 Chiron Springs
Offices, Etna Rd.
Lebanon,  NH  03766
Correspondent Contact DENNIS WM. COOMBS
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received08/02/1993
Decision Date 01/31/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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