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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 K961050
Device Name RELIEFBAND TENS UNIT (MODIFICATION)
Applicant
MAVEN LABS, INC.
1233 20TH ST. N.W.
SUITE 700
WASHINGTON,  DC  20036
Applicant Contact DANIEL J MANELLI
Correspondent
MAVEN LABS, INC.
1233 20TH ST. N.W.
SUITE 700
WASHINGTON,  DC  20036
Correspondent Contact DANIEL J MANELLI
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/08/1996
Decision Date 08/01/1997
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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