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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K050718
Device Name DDRCOMBI TRAUMA
Applicant
Swissray International, Inc.
1180 Mclester St.
Elizabeth,  NJ  07201
Applicant Contact JOHN MONAHAN
Correspondent
Swissray International, Inc.
1180 Mclester St.
Elizabeth,  NJ  07201
Correspondent Contact JOHN MONAHAN
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/21/2005
Decision Date 05/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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