510(k) K771109

Device: ORTHOPEDIC SOFT GOODS
Applicant: Orthopedic Systems, Inc.
510(k) number: K771109
Product code: HSS
Decision: Substantially Equivalent (SESE)
Decision date: 1977-06-27
Date received: 1977-06-20
Regulation: 888.5890
Classification name: Halter, Head, Traction
Medical specialty: Orthopedic
Review panel: Orthopedic
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 HSS#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K770910	MEDISHIELD CERVICAL COLLAR	Fraser Sweatman, Inc.	1977-05-25
K760869	SPLIT CERVICAL COLLAR/HEAD HALTER	Orthopedic Equipment Co., Inc.	1976-11-01