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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 K961809
Device Name SHE-LI TENS STIMULATOR MODEL SL-101 RX
Applicant
MEDI CONSULTANTS, INC.
265 VREELAND AVE.
PATERSON,  NJ  07504
Applicant Contact SAUL LISS
Correspondent
MEDI CONSULTANTS, INC.
265 VREELAND AVE.
PATERSON,  NJ  07504
Correspondent Contact SAUL LISS
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/10/1996
Decision Date 02/26/1997
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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