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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, Tomographic
510(k) Number K925302
Device Name PHILIPS INTEGRIS H/HM SYSTEM
Applicant
Philips Medical Systems, Inc.
Veenpluis 4-6
P.O. Box 10000
5680 Da Best,  NL
Applicant Contact WILLIAM G MCMAHON
Correspondent
Philips Medical Systems, Inc.
Veenpluis 4-6
P.O. Box 10000
5680 Da Best,  NL
Correspondent Contact WILLIAM G MCMAHON
Regulation Number892.1740
Classification Product Code
IZF  
Date Received10/21/1992
Decision Date 12/17/1992
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
Recalls CDRH Recalls
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