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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aperture, Radiographic
510(k) Number K895084
Device Name APERTURE
Applicant
Custom Medical Products, Ltd.
19a W. Industry Court
Deer Park,  NY  11729
Applicant Contact JAMES COLLETTE
Correspondent
Custom Medical Products, Ltd.
19a W. Industry Court
Deer Park,  NY  11729
Correspondent Contact JAMES COLLETTE
Regulation Number892.1610
Classification Product Code
IZS  
Date Received08/14/1989
Decision Date 10/27/1989
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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