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510(k) K843406

Device
CHEW-DENT
Applicant
SENAIR-MOT
510(k) number
K843406
Product code
JEW  
Decision
Substantially Equivalent (SESE)
Decision date
1984-12-11
Date received
1984-08-31
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
RICHARD G DENIRO
Address
1500 E. Katella Ave. Orange CA US 92667 92667

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
K790588ASSAY REAGENTS, LSA 290Kallestad Laboratories, Inc.1979-05-15

Legacy Summary#

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FDA Review#

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