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510(k) K834540

Device
OP-CON SURGICAL INSTRUMENT #9
Applicant
IMM ENTERPRISES LTD.
510(k) number
K834540
Product code
KBN  
Decision
Substantially Equivalent (SESE)
Decision date
1984-03-06
Date received
1983-12-01
Regulation
874.4420
Classification name
Gag, Mouth
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KBN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K822183MOUTH GAGSKelleher Corp.1982-08-16
K780992MILLARD MOUTH GAGNestor Engineering Associates, Inc.1978-08-17

Legacy Summary#

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FDA Review#

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