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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 K133502
Device Name 5000Z FIREFLY SYSTEM
Applicant
Prizm Medical, Inc.
2888 Forest Ridge
Chaska,  MN  55318
Applicant Contact CARL BEAURLINE
Correspondent
Prizm Medical, Inc.
1236 Doker Dr.
Modesto,  CA  95351
Correspondent Contact James P. Johnson
Regulation Number882.5890
Classification Product Code
NUH  
Date Received11/14/2013
Decision Date 12/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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