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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 K941959
Device Name VERSATELL; VERSATELL-S
Applicant
Progressive Concepts, Inc.
22194 Hillsboro Rd.
Denton,  MD  21629
Applicant Contact RAY FISCHER
Correspondent
Progressive Concepts, Inc.
22194 Hillsboro Rd.
Denton,  MD  21629
Correspondent Contact RAY FISCHER
Regulation Number882.5050
Classification Product Code
HCC  
Date Received04/22/1994
Decision Date 06/21/1995
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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