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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K950041
Device Name SII 360 APR
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 Number892.1700
Classification Product Code
IZO  
Date Received01/05/1995
Decision Date 03/21/1995
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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