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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Tissue, Automated
510(k) Number K881165
Device Name SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR
Applicant
Sakura Finetek U.S.A., Inc.
23440 Hawthorne Blvd.
Suite 240
Torrance,  CA  90505
Applicant Contact ROBERT A CLARK
Correspondent
Sakura Finetek U.S.A., Inc.
23440 Hawthorne Blvd.
Suite 240
Torrance,  CA  90505
Correspondent Contact ROBERT A CLARK
Regulation Number864.3875
Classification Product Code
IEO  
Date Received03/20/1988
Decision Date 07/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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