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510(k) K874543

Device
MODEL OPO-32 IRRIGATION SLEEVE
Applicant
ALLERGAN, INC.
510(k) number
K874543
Product code
EIB  
Decision
Substantially Equivalent (SESE)
Decision date
1988-01-14
Date received
1987-11-03
Regulation
872.4565
Classification name
Syringe, Irrigating (dental)
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAUL S KRAMSKY
Address
Post Office Box 25155 Santa Ana CA US 92799 92799

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EIB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K911118DTF-1000LL,DTF-1000Cp Medical1991-11-20
K822411SYSTEM 80 FACEPLATE-IN-THE-EAR #F1Western Advanced Technology, Inc.1983-07-12
K760570ROBINSON MIDDLE EAR PROSTHESISXomed, Inc.1976-09-21

Legacy Summary#

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FDA Review#

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