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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 K921110
Device Name TENS
Applicant
Staodyne, Inc.
1225 Florida Ave.
P.O Box 1379
Longmont,  CO  80502 -1379
Applicant Contact THOMAS W ROBIRDS
Correspondent
Staodyne, Inc.
1225 Florida Ave.
P.O Box 1379
Longmont,  CO  80502 -1379
Correspondent Contact THOMAS W ROBIRDS
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/09/1992
Decision Date 08/14/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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