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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Densitometer, Bone
510(k) Number K091325
Device Name TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS
Applicant
Cooper Surgical
95 Corporate Dr.
Trumbull,  CT  06611
Applicant Contact THOMAS G WILLIAMS
Correspondent
Cooper Surgical
31 Gordan Rd.
Piscataway,  NJ  08854
Correspondent Contact John Monahan
Regulation Number892.1170
Classification Product Code
KGI  
Date Received05/05/2009
Decision Date 06/29/2009
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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