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510(k) K822305

Device
ORTHO-LEVEL
Applicant
FRONTIER PRODUCTS
510(k) number
K822305
Product code
HTH  
Decision
Substantially Equivalent (SESE)
Decision date
1982-08-20
Date received
1982-07-27
Regulation
888.4600
Classification name
Protractor
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HTH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K861576SHORTENING OSTEOTOMY GUIDEOsteotomy Guide Co.1986-05-12
K841470REESE OSTEOTOMY GUIDE SYSOsteotomy Guide Co.1984-05-23

Legacy Summary#

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FDA Review#

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