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510(k) K881466

Device
CELL-CULTURE SHAKER
Applicant
CRYODYNE TECHNOLOGIES, INC.
510(k) number
K881466
Product code
KJB  
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-18
Date received
1988-04-06
Regulation
864.2240
Classification name
Apparatus, Roller
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DEAN W SCHILLING
Address
400 Hoover Rd. Soquel CA US 95073 95073

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KJB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K872076CORNING DISPOSABLE ROLLER BOTTLESCorning Medical & Scientific1987-06-15
K852506BIOGLAS MICROCARRIER BEADSolohill Engineering, Inc.1985-07-12

Legacy Summary#

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FDA Review#

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