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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, Over-The-Counter
510(k) Number K033122
Device Name 5000Z SYSTEM (OTC)
Applicant
PRIZM MEDICAL, INC.
5536 TROWBRIDGE DR.
DUNWOODY,  GA  30338
Applicant Contact CATHRYN N CAMBRIA
Correspondent
PRIZM MEDICAL, INC.
5536 TROWBRIDGE DR.
DUNWOODY,  GA  30338
Correspondent Contact CATHRYN N CAMBRIA
Regulation Number882.5890
Classification Product Code
NUH  
Date Received09/30/2003
Decision Date 08/25/2004
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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