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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
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