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510(k) K840311

Device
CAT. 7-EAR, NOSE & THROAT DEVICES
Applicant
IMM ENTERPRISES LTD.
510(k) number
K840311
Product code
KCP  
Decision
Substantially Equivalent (SESE)
Decision date
1984-05-09
Date received
1984-01-24
Regulation
874.5220
Classification name
Syringe, Ent
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 KCP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K822754EAR/ULCER SYRINGEAmerican Hospital Supply Corp.1982-10-04
K810284AUTOMATIC TEFLON INJECTION SYRINGER. Wolf Medical Instruments Corp.1981-03-11
K780599SYRINGE, EAR & ULCERAbco Dealers, Inc.1978-04-19

Legacy Summary#

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FDA Review#

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