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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 K880905
Device Name MAMMOGRAPHY MOVING GRID BUCKY
Applicant
Custom Medical Products, Ltd.
19a W. Industry Ct.
Deer Park,  NY  11729
Applicant Contact JAMES COLLETTE
Correspondent
Custom Medical Products, Ltd.
19a W. Industry Ct.
Deer Park,  NY  11729
Correspondent Contact JAMES COLLETTE
Regulation Number892.1710
Classification Product Code
IZH  
Date Received03/02/1988
Decision Date 03/21/1988
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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