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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 K933711
Device Name E-SP COMBINED EPIDURAL-SPINAL ANESTHESIA TRAY
Applicant
Neurodelivery Technology, Inc.
Chiron Springs Offices
Etna Rd.
Labanon,  NH  03766
Applicant Contact DENNIS WM. COOMBS
Correspondent
Neurodelivery Technology, Inc.
Chiron Springs Offices
Etna Rd.
Labanon,  NH  03766
Correspondent Contact DENNIS WM. COOMBS
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received07/30/1993
Decision Date 11/22/1993
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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