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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cradle, Patient, Radiologic
510(k) Number K863890
Device Name MAMM-AIRE
Applicant
Ar Custom Medical Products, Ltd.
19a W. Industry Ct.
Deer Park,  NY  11729
Applicant Contact JAMES COLLETTE
Correspondent
Ar Custom Medical Products, Ltd.
19a W. Industry Ct.
Deer Park,  NY  11729
Correspondent Contact JAMES COLLETTE
Regulation Number892.1830
Classification Product Code
KXH  
Date Received10/06/1986
Decision Date 10/14/1986
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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