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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, Stationary
510(k) Number K052943
Device Name DDRFORMULA AND DDRFORMULA PLUS
Applicant
Swissray Medical AG
1180 Mclester St., Unit#2
Elizabeth,  NJ  07201
Applicant Contact JOHN MONAHAN
Correspondent
Swissray Medical AG
1180 Mclester St., Unit#2
Elizabeth,  NJ  07201
Correspondent Contact JOHN MONAHAN
Regulation Number892.1680
Classification Product Code
KPR  
Date Received10/20/2005
Decision Date 12/15/2005
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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