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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 K934526
Device Name MICRO-SP CUSTOM SPINAL ANESTHESIA TRAY
Applicant
Neurodelivery Technology, Inc.
P.O. Box 548 Chiron Springs
Offices, Etna Rd.
Lebanon,  NH  03766
Applicant Contact DENNIS W COOMBS
Correspondent
Neurodelivery Technology, Inc.
P.O. Box 548 Chiron Springs
Offices, Etna Rd.
Lebanon,  NH  03766
Correspondent Contact DENNIS W COOMBS
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received09/20/1993
Decision Date 01/28/1994
Decision Substantially Equivalent (SESE)
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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