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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 K864334
Device Name ACUSYST-P (CELL CULTURE EQUIPMENT)
Applicant
Endotronics, Inc.
8500 Evergreen Blvd.
Coon Rapids,  MN  55433
Applicant Contact BERNARD HORWATH
Correspondent
Endotronics, Inc.
8500 Evergreen Blvd.
Coon Rapids,  MN  55433
Correspondent Contact BERNARD HORWATH
Regulation Number864.2240
Classification Product Code
KJH  
Date Received11/04/1986
Decision Date 11/24/1986
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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