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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K933512
Device Name UPSCAN
Applicant
Merlin Engineering Works, Inc.
1888 Embarcadero Rd.
Palo Alto,  CA  94303
Applicant Contact ROBERT VAN WALDELEN
Correspondent
Merlin Engineering Works, Inc.
1888 Embarcadero Rd.
Palo Alto,  CA  94303
Correspondent Contact ROBERT VAN WALDELEN
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
LMA  
Date Received07/20/1993
Decision Date 04/19/1995
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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