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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Mount, X-Ray, Diagnostic
510(k) Number K946261
Device Name MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000
Applicant
Scott Imaging Intl., Inc.
3510 Cottage Hill Rd.
Mobile,  AL  36609
Applicant Contact MICHAEL W SCOTT
Correspondent
Scott Imaging Intl., Inc.
3510 Cottage Hill Rd.
Mobile,  AL  36609
Correspondent Contact MICHAEL W SCOTT
Regulation Number892.1770
Classification Product Code
IYB  
Date Received12/13/1994
Decision Date 02/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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