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510(k) K863146

Device
BOWEN SUTURE PASSER
Applicant
BOWEN & COMPANY, INC.
510(k) number
K863146
Product code
HXI  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-05
Date received
1986-08-15
Regulation
888.4540
Classification name
Passer, Wire, Orthopedic
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CAROL APPLE
Address
1800 Chapman Ave. Rockville MD US 20852 20852

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HXI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140576Y WIRE 2Safewire, LLC2014-05-20
K863148BOWEN KNOT PASSERBowen & Company, Inc.1986-09-05

Legacy Summary#

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FDA Review#

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