510(k) K770891

Device: SPLINH, FOREARM
Applicant: Orthopedic Systems, Inc.
510(k) number: K770891
Product code: IQM
Decision: Substantially Equivalent (SESE)
Decision date: 1977-05-26
Date received: 1977-05-16
Regulation: 890.3025
Classification name: Splint, Temporary Training
Medical specialty: Physical Medicine
Review panel: Physical Medicine
Device class: 1
Clearance type: Traditional
Third party reviewed: N

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 IQM#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K771287	FINGEO EXTENSION SPLINTS	Fred Sammons, Inc.	1977-07-21
K770890	SPLINT, COCKUP	Orthopedic Systems, Inc.	1977-05-26