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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K031590
Device Name SECTRA ORTHOPEDIC 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 Number892.2050
Classification Product Code
LLZ  
Date Received05/21/2003
Decision Date 10/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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