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510(k) K862635

Device
RABINOWITZ GUM MASSAGER
Applicant
ARNELL, INC.
510(k) number
K862635
Product code
JEW  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-25
Date received
1986-07-10
Regulation
872.6650
Classification name
Tip, Rubber, Oral Hygiene
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LEWIS RABINOWITZ
Address
7016 N. 57th Ave. Glendale AZ US 85301 85301

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
K843406CHEW-DENTSenair-Mot1984-12-11
K790588ASSAY REAGENTS, LSA 290Kallestad Laboratories, Inc.1979-05-15

Legacy Summary#

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FDA Review#

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