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510(k) K790588

Device
ASSAY REAGENTS, LSA 290
Applicant
KALLESTAD LABORATORIES, INC.
510(k) number
K790588
Product code
JEW  
Decision
Substantially Equivalent (SESE)
Decision date
1979-05-15
Date received
1979-03-27
Regulation
872.6650
Classification name
Tip, Rubber, Oral Hygiene
Medical specialty
Dental
Review panel
Immunology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JEW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862635RABINOWITZ GUM MASSAGERArnell, Inc.1986-09-25
K843406CHEW-DENTSenair-Mot1984-12-11

Legacy Summary#

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FDA Review#

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