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510(k) K923880

Device
ORLAU SWIVEL WALKER
Applicant
MOPAC, LTD.
510(k) number
K923880
Product code
MRI  
Decision
Substantially Equivalent (SESE)
Decision date
1996-09-30
Date received
1992-07-31
Regulation
890.3490
Classification name
Orthosis, Truncal/orthosis, Limb
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN STAHL
Address
P.O. Box 3094 Eau Claire WI US 54702 54702

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MRI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973031STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTER. Thomas Grotz, M.D., Inc.1997-11-03

Legacy Summary#

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FDA Review#

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