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510(k) K882407

Device
BOW & ARROW DRILL GUIDE
Applicant
INSTRUMENT MAKAR, INC.
510(k) number
K882407
Product code
LXI  
Decision
Substantially Equivalent (SESE)
Decision date
1988-09-06
Date received
1988-06-10
Regulation
878.4820
Classification name
Guide, Drill, Ligament
Medical specialty
General & Plastic Surgery
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DEAN Z LOOK
Address
2950 E. Mt. Hope Rd. Okemos MI US 48864 48864

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LXI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K930573SYNVASIVE CERAMIC SUTTING BLOCKSynvasive Technology, Inc.1994-04-07
K910712VILLAN (VIDEO LIFT LINK ANALYSIS)Physio Systems, Inc.1991-05-21
K892655ACL DRILL GUIDE SYSTEMBaxter Healthcare Corp1989-09-28
K890445PERSONAL ALERT ASSIST DEVICESilent Call Corp.1989-05-19
K881378PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDEPfizer, Inc.1988-06-17
K880739DYONICS DRILL GUIDE/ISOMETER SYSTEMDyonics, Inc.1988-03-21
K854254TENSION-ISOMETERMedmetric Corp.1985-11-15

Legacy Summary#

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FDA Review#

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