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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K854203
Device Name TEC 2720 MAMEX DC MAG
Applicant
Tecnomed, Inc.
235 S. Fehr Way
Bay Shore,  NY  11706
Applicant Contact JEAN GRISWOLD
Correspondent
Tecnomed, Inc.
235 S. Fehr Way
Bay Shore,  NY  11706
Correspondent Contact JEAN GRISWOLD
Regulation Number892.1710
Classification Product Code
IZH  
Date Received10/16/1985
Decision Date 03/06/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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