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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, Mobile
510(k) Number K923359
Device Name PORT-XP
Applicant
Mobile Dental Equipment Corp.
16604 SE 17th Pl.
Bellevue,  WA  98008
Applicant Contact PETER E MOORE
Correspondent
Mobile Dental Equipment Corp.
16604 SE 17th Pl.
Bellevue,  WA  98008
Correspondent Contact PETER E MOORE
Regulation Number892.1720
Classification Product Code
IZL  
Date Received07/08/1992
Decision Date 04/07/1993
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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