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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 K980333
Device Name RELIEFBAND
Applicant
WOODSIDE BIOMEDICAL, INC.
18140 SMOKESIGNAL DR.
SAN DIEGO,  CA  92127
Applicant Contact CAROL PATTERSON
Correspondent
WOODSIDE BIOMEDICAL, INC.
18140 SMOKESIGNAL DR.
SAN DIEGO,  CA  92127
Correspondent Contact CAROL PATTERSON
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received01/28/1998
Decision Date 02/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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