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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 K971154
Device Name MULTIPICS(ME-977)
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 Number892.2020
Classification Product Code
LMD  
Date Received03/28/1997
Decision Date 06/25/1997
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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