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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 K013507
Device Name COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH
Applicant
COSMO HEALTH INC.
1129 BLOOMFLIED AVE.
WEST CALDWELL,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
COSMO HEALTH INC.
1129 BLOOMFLIED AVE.
WEST CALDWELL,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/22/2001
Decision Date 01/25/2002
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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