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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 K982321
Device Name VECTRA STIM MODELS 200 AND 400
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
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
Predetermined Change
Control Plan Authorized		 No
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