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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 K860129
Device Name ISO-MAMMO
Applicant
Philips Medical Systems (Cleveland), Inc.
5500 Avion Park Dr.
Highland Heights,  OH  44143
Applicant Contact WILLIAM GERBER
Correspondent
Philips Medical Systems (Cleveland), Inc.
5500 Avion Park Dr.
Highland Heights,  OH  44143
Correspondent Contact WILLIAM GERBER
Regulation Number892.1710
Classification Product Code
IZH  
Date Received01/14/1986
Decision Date 03/06/1986
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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