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510(k) K881378

Device
PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE
Applicant
PFIZER, INC.
510(k) number
K881378
Product code
LXI  
Decision
Substantially Equivalent (SESE)
Decision date
1988-06-17
Date received
1988-04-01
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
JOSEPH E LAPTEWICZ
Address
Eastern Pt. Rd. Groton CT US 06340 06340

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
K882407BOW & ARROW DRILL GUIDEInstrument Makar, Inc.1988-09-06
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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