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510(k) K834169

Device
OP-CON SURGICAL INSTRUMENT #9
Applicant
IMM ENTERPRISES LTD.
510(k) number
K834169
Product code
BWB  
Decision
Substantially Equivalent (SESE)
Decision date
1984-01-17
Date received
1983-11-21
Regulation
868.5780
Classification name
Forceps, Tube Introduction
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BWB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884584TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADSEastmed Enterprises, Inc.1988-11-14
K880318ROVENSTEIN FORCEPSEastmed Enterprises, Inc.1988-03-21
K880319MAGILL FORCEPSEastmed Enterprises, Inc.1988-03-21
K840313CAT. 9 ANESTHESIOLOGY RESPIRATORY DEVImm Enterprises , Ltd.1984-02-04
K820451INTRODUCER FOR ENDOTRACHEAL TUBEImed Corp.1982-03-26

Legacy Summary#

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FDA Review#

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