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510(k) K864334

Device
ACUSYST-P (CELL CULTURE EQUIPMENT)
Applicant
ENDOTRONICS, INC.
510(k) number
K864334
Product code
KJH  
Decision
Substantially Equivalent (SESE)
Decision date
1986-11-24
Date received
1986-11-04
Regulation
864.2240
Classification name
Apparatus, Perfusion
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BERNARD HORWATH
Address
8500 Evergreen Blvd. Coon Rapids MN US 55433 55433

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KJH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K875151ACUSYST-P/3XEndotronics, Inc.1988-01-12
K872086ACUSYST-JREndotronics, Inc.1987-06-15

Legacy Summary#

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FDA Review#

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