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510(k) K860058

Device
DENPAX
Applicant
NISSHO IWAI AMERICAN CORP.
510(k) number
K860058
Product code
EBR  
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-12
Date received
1986-01-06
Regulation
872.6640
Classification name
Unit, Suction Operatory
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LIU
Address
1211 Ave. Of The Americas New York NY US 10036 10036

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EBR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K925367A-DEC 7284 CUSPIDOR, CASCADEA-Dec, Inc.1994-04-11
K770600OROPHARYNGEAL SUCTION AIRWAYW.H. Wall, D.D.S.1977-04-08

Legacy Summary#

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FDA Review#

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