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510(k) K971639

Device
PLUSTRON ION TOOTHBRUSH SYSTEM
Applicant
SAS GROUP, INC.
510(k) number
K971639
Product code
MMD  
Decision
Substantially Equivalent (SESE)
Decision date
1997-06-24
Date received
1997-05-02
Regulation
872.6865
Classification name
Toothbrush, Ionic, Battery-powered
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL D SOBO
Address
220 White Plains Rd. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MMD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K915576HUBUKA HYG TOOTHBRUSHHukuba Dental Corp.1994-03-04

Legacy Summary#

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FDA Review#

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