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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Perfusion
510(k) Number K872086
Device Name ACUSYST-JR
Applicant
Endotronics, Inc.
8500 Evergreen Blvd.
Coon Rapids,  MN  55433
Applicant Contact BERNARD E HORWATH
Correspondent
Endotronics, Inc.
8500 Evergreen Blvd.
Coon Rapids,  MN  55433
Correspondent Contact BERNARD E HORWATH
Regulation Number864.2240
Classification Product Code
KJH  
Date Received06/01/1987
Decision Date 06/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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