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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, transcutaneous, for pain relief
510(k) Number K042912
FOIA Releasable 510(k) K042912
Device Name INTERX5000
Applicant
NEURO RESOURCE GROUP, INC.
2220 CHEMSEARCH BLVD.
SUITE 108
IRVING,  TX  75062
Applicant Contact KRISTA OAKES
Correspondent
NEURO RESOURCE GROUP, INC.
2220 CHEMSEARCH BLVD.
SUITE 108
IRVING,  TX  75062
Correspondent Contact KRISTA OAKES
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/21/2004
Decision Date 05/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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