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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K970451
Device Name DOWNSCAN 120
Applicant
Merlin Engineering Works, Inc.
1888 Embarcadero Rd.
Palo Alto,  CA  94303
Applicant Contact GERALD ENGBRETSON
Correspondent
Merlin Engineering Works, Inc.
1888 Embarcadero Rd.
Palo Alto,  CA  94303
Correspondent Contact GERALD ENGBRETSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/06/1997
Decision Date 04/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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