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510(k) K772390

Device
DAY EAR HOOK
Applicant
EDWARD WECK, INC.
510(k) number
K772390
Product code
JYL  
Decision
Substantially Equivalent (SESE)
Decision date
1978-01-17
Date received
1977-12-27
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
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 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
K822166MICROSURGICAL EAR HOOKKelleher Corp.1982-08-20
K780287DAY HEAR HOOKEdward Weck, Inc.1978-02-27

Legacy Summary#

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FDA Review#

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