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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 STREET, UNIT #2
ELIZABETH,  NJ  07201
Applicant Contact JOHN MONAHAN
Correspondent
SWISSRAY MEDICAL AG
1180 MCLESTER STREET, 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
Recalls CDRH Recalls
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