510(k) K821178

Device: Ethicon External Fixation Wire
Applicant: ETHICON, INC.
510(k) number: K821178
Product code: FYI
Decision: Substantially Equivalent (SESE)
Decision date: 1983-06-11
Date received: 1982-04-27
Regulation: 878.3250
Classification name: Appliance, Facial Fracture, External
Medical specialty: General, Plastic Surgery
Review panel: General, Plastic Surgery
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

1836161
8030607
3005587147

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FYI#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K871073	OMEGA BIVALVE NASAL SPLINTS	Omega Silicone, Inc.	1987-05-11
K801072	STRAITH NASAL SPLINT	Surgical Technology Laboratories, Inc.	1980-06-17
K792106	CONPHAR O.R. HEAD COVER-STERILE	Conphar, Inc.	1979-11-05