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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K953398
Device Name UNISCAN
Applicant
Merlin Engineering Works, Inc.
1888 Embarcadero Rd.
Palo Alto,  CA  94303
Applicant Contact GENERALD ENGBRESTON
Correspondent
Merlin Engineering Works, Inc.
1888 Embarcadero Rd.
Palo Alto,  CA  94303
Correspondent Contact GENERALD ENGBRESTON
Regulation Number892.2020
Classification Product Code
LMD  
Date Received07/20/1995
Decision Date 10/06/1995
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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