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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 K071546
Device Name EOS
Applicant
Biospace Med
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact JOHN J SMITH
Correspondent
Biospace Med
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact JOHN J SMITH
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received06/06/2007
Decision Date 09/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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