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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 K982324
Device Name VECTRA PRO MODELS 2 AND 4
Applicant
CHATTANOOGA GROUP, INC.
4717 ADAMS RD.
P.O. BOX 4287
HIXSON,  TN  37343
Applicant Contact CHERYL G DYER
Correspondent
CHATTANOOGA GROUP, INC.
4717 ADAMS RD.
P.O. BOX 4287
HIXSON,  TN  37343
Correspondent Contact CHERYL G DYER
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
IMG   IMI   IPF   LIH  
Date Received07/02/1998
Decision Date 02/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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