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510(k) K822166

Device
MICROSURGICAL EAR HOOK
Applicant
KELLEHER CORP.
510(k) number
K822166
Product code
JYL  
Decision
Substantially Equivalent (SESE)
Decision date
1982-08-20
Date received
1982-07-23
Regulation
874.4420
Classification name
Hook, Microsurgical Ear
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 JYL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K834188JAKOBI SURG. INSTRUMENTS #7 10/43Imm Enterprises , Ltd.1984-03-06
K822195MIRCOSURGICAL INSTRUMENTSKelleher Corp.1982-08-25
K780287DAY HEAR HOOKEdward Weck, Inc.1978-02-27
K772390DAY EAR HOOKEdward Weck, Inc.1978-01-17

Legacy Summary#

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FDA Review#

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