510(k) K893787

Device
Lifecell Recovery Container
Applicant
BAXTER HEALTHCARE CORP.
510(k) number
K893787
Product code
KJF
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-23
Date received
1989-05-22
Regulation
864.2240
Classification name
System, Suspension, Cell Culture
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DONALD H BUCHHOLZ
Address
Rte. 120 And Wilson Rd. Round Lake IL US 60073 60073

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KJF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K892645AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SYAmicon, Inc.1989-06-13
K875221TOOTH PRESERVING SYSTEMBiological Rescue Products, Inc.1988-04-14
K780305CELLDynatech Laboratories, Inc.1978-03-27