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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K861796
Device Name FITTRONIC
Applicant
Corleone Intl. Traders, Inc.
P.O. Box 3417
5617 Hollywood Blvd., #101
Los Angeles,  CA  90028
Applicant Contact HARRY H KAZAKIAN
Correspondent
Corleone Intl. Traders, Inc.
P.O. Box 3417
5617 Hollywood Blvd., #101
Los Angeles,  CA  90028
Correspondent Contact HARRY H KAZAKIAN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/09/1986
Decision Date 06/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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