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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K954127
Device Name BIOFEEDBACK DEVICE
Applicant
Verimed Holdings, Inc.
11950 NW 39th St., Suite D
Coral Springs,  FL  33065
Applicant Contact CHRISTOPHER J CHASE
Correspondent
Verimed Holdings, Inc.
11950 NW 39th St., Suite D
Coral Springs,  FL  33065
Correspondent Contact CHRISTOPHER J CHASE
Regulation Number882.5050
Classification Product Code
HCC  
Date Received08/31/1995
Decision Date 11/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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