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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 K092117
Device Name SCENAR, MODEL 10
Applicant
RITM OKB ZAO
99, PETROVSKAYA
taganrog,  RU 347900
Applicant Contact larisa shpungina
Correspondent
RITM OKB ZAO
99, PETROVSKAYA
taganrog,  RU 347900
Correspondent Contact larisa shpungina
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/14/2009
Decision Date 05/28/2010
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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