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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 K021527
Device Name SECTRA OSTEOPOROSIS PACKAGE
Applicant
Sectra-Imtec AB
1100 Lakeview Blvd.
Denton,  TX  76208
Applicant Contact CARL ALLETTO
Correspondent
Sectra-Imtec AB
1100 Lakeview Blvd.
Denton,  TX  76208
Correspondent Contact CARL ALLETTO
Regulation Number892.1170
Classification Product Code
KGI  
Date Received05/10/2002
Decision Date 06/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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