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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Electroconductive
510(k) Number K032239
Device Name THERA-CREAM, MODEL TCT004
Applicant
Prizm Medical, Inc.
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Applicant Contact JULIE STEPHENS
Correspondent
Prizm Medical, Inc.
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Correspondent Contact JULIE STEPHENS
Regulation Number882.1275
Classification Product Code
GYB  
Date Received07/21/2003
Decision Date 07/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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