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510(k) K851789

Device
29-200 TO 29-230 VARIOUS BONE MALLETS(WIHIGER, DOY
Applicant
ARTIBERIA
510(k) number
K851789
Product code
GFJ  
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-20
Date received
1985-04-25
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#

Contact
GIL M SANCHEZ
Address
4518 Los Ranchitos San Antonio TX US 78233 78233

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
K844017MICROTENS 7757 T.E.N.S. STIMULATORRabar, Inc.1984-11-30
K822204ENT MALLETSKelleher Corp.1982-09-17

Legacy Summary#

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FDA Review#

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