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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K893681
Device Name MAMM-AIRE CP
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 Number892.1700
Classification Product Code
IZO  
Date Received05/16/1989
Decision Date 07/20/1989
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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