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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Automatic, Radiographic
510(k) Number K862340
Device Name SENTEC LASER GUIDE LINE, MODEL SGL-05
Applicant
Sentec Corp.
460 N. Woodward
Birmingham,  MI  48011
Applicant Contact SAWATARI, PHD
Correspondent
Sentec Corp.
460 N. Woodward
Birmingham,  MI  48011
Correspondent Contact SAWATARI, PHD
Regulation Number892.1610
Classification Product Code
IZW  
Date Received06/20/1986
Decision Date 07/11/1986
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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