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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 K042003
Device Name INFINITY TRIDENT NMT POD
Applicant
Draeger Medical Systems, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact PENELOPE H GRECO
Correspondent
Draeger Medical Systems, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact PENELOPE H GRECO
Regulation Number868.2775
Classification Product Code
KOI  
Date Received07/26/2004
Decision Date 09/01/2004
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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