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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 K892342
Device Name TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM
Applicant
Bay Shore Medical Equipment Corp.
Tecnomed Usa
235 S. Fehr Way
Bay Shore,  NY  11706
Applicant Contact JEAN GRISWOLD
Correspondent
Bay Shore Medical Equipment Corp.
Tecnomed Usa
235 S. Fehr Way
Bay Shore,  NY  11706
Correspondent Contact JEAN GRISWOLD
Regulation Number892.1710
Classification Product Code
IZH  
Date Received04/05/1989
Decision Date 11/17/1989
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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