510(k) K772384

Device: Myringotomy Knife
Applicant: EDWARD WECK, INC.
510(k) number: K772384
Product code: JYO
Decision: Substantially Equivalent (SESE)
Decision date: 1978-01-17
Date received: 1977-12-27
Regulation: 874.4420
Classification name: Knife, Ear
Medical specialty: Ear, Nose, Throat
Review panel: Ear, Nose, Throat
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 JYO#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K910212	COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST	Acoustic Imaging Technologies Corp.	1991-07-11
K841006	EAR KNIFE-VARIOUS	Premier Dental Products Co.	1984-05-30
K840764	EAR KNIVES	Sharpoint, Inc.	1984-05-21
K833602	ROLLER KNIFE-TRANSVERSE -SAGITTAL	Microtek Medical, Inc.	1984-01-03
K823911	KNIFE BLADE TIP	Treace Medical, Inc.	1983-01-21
K772372	ROLLER KNIFE	Edward Weck, Inc.	1978-01-17