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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Peripheral, Electric
510(k) Number K955026
Device Name AS/3 NMT MODULE
Applicant
Datex Medical Instrumentation, Inc.
2 Highwood Dr.
Tewksbury,  MA  01876
Applicant Contact JOEL KENT
Correspondent
Datex Medical Instrumentation, Inc.
2 Highwood Dr.
Tewksbury,  MA  01876
Correspondent Contact JOEL KENT
Regulation Number868.2775
Classification Product Code
KOI  
Date Received11/02/1995
Decision Date 04/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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