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510(k) K822204

Device
ENT MALLETS
Applicant
KELLEHER CORP.
510(k) number
K822204
Product code
GFJ  
Decision
Substantially Equivalent (SESE)
Decision date
1982-09-17
Date received
1982-07-23
Regulation
878.4800
Classification name
Mallet, Surgical, General & Plastic Surgery
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
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 GFJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K85178929-200 TO 29-230 VARIOUS BONE MALLETS(WIHIGER, DOYArtiberia1985-06-20
K844017MICROTENS 7757 T.E.N.S. STIMULATORRabar, Inc.1984-11-30

Legacy Summary#

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FDA Review#

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