510(k) K770812

Device: HANDLES, LIGHT, SURGICAL, STEOILE
Applicant: Sybron Corp.
510(k) number: K770812
Product code: FQP
Decision: Substantially Equivalent (SESE)
Decision date: 1977-05-23
Date received: 1977-05-03
Regulation: 878.4580
Classification name: Lamp, Operating-Room
Medical specialty: General, Plastic Surgery
Review panel: General, Plastic Surgery
Device class: 2
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 FQP#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K001223	ACULUX, MODEL AX3001, AX3002	Aculux	2000-06-23
K993314	SYNTHES LIGHT GUIDE	Synthes (Usa)	1999-12-06
K781581	SURGICAL LIGHT 22 SERIES	American Sterilizer Co.	1978-10-17
K761018	SURGICAL LIGHT - CHALLENGE 22 SERIES	Amsco Co.	1977-01-26