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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K913067
Device Name DGH-4000 A-SCAN/PACHYMETER
Applicant
Dgh Technology, Inc.
446 Lancaster Ave.
Frazer,  PA  19355
Applicant Contact LUTHER DETWEILER
Correspondent
Dgh Technology, Inc.
446 Lancaster Ave.
Frazer,  PA  19355
Correspondent Contact LUTHER DETWEILER
Regulation Number892.1560
Classification Product Code
IYO  
Date Received07/11/1991
Decision Date 01/31/1992
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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