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510(k) K834198

Device
JAKOBI SURG. INSTRUMENTS #12 40/41
Applicant
IMM ENTERPRISES LTD.
510(k) number
K834198
Product code
FZO  
Decision
Substantially Equivalent (SESE)
Decision date
1984-01-27
Date received
1983-11-21
Regulation
878.4800
Classification name
Chisel, Surgical, Manual
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 FZO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K85178829-140 TO 29-196 VARIOUS BONE CHISELS (OSTEOTOMES,Artiberia1985-06-20

Legacy Summary#

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FDA Review#

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