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510(k) K760570

Device
ROBINSON MIDDLE EAR PROSTHESIS
Applicant
XOMED, INC.
510(k) number
K760570
Product code
EIB  
Decision
Substantially Equivalent (SESE)
Decision date
1976-09-21
Date received
1976-09-01
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#

Address
1318 Lonedell Rd. Arnold MO US 63010 63010

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
K874543MODEL OPO-32 IRRIGATION SLEEVEAllergan, Inc.1988-01-14
K822411SYSTEM 80 FACEPLATE-IN-THE-EAR #F1Western Advanced Technology, Inc.1983-07-12

Legacy Summary#

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FDA Review#

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