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510(k) K896364

Device
DECIDENT
Applicant
NEVIN LABORATORIES, INC.
510(k) number
K896364
Product code
EKY  
Decision
Substantially Equivalent (SESE)
Decision date
1990-07-19
Date received
1989-11-06
Regulation
872.4200
Classification name
Handpiece, Water-powered
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT L NEVIN
Address
5000 S. Halsted St. Chicago IL US 60609 60609

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EKY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123695TRAUS SIP10Saeshin Precision Co., Ltd.2012-12-18

Legacy Summary#

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FDA Review#

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