510(k) K810284

Device: Automatic Teflon Injection Syringe
Applicant: R. WOLF MEDICAL INSTRUMENTS CORP.
510(k) number: K810284
Product code: KCP
Decision: Substantially Equivalent (SESE)
Decision date: 1981-03-11
Date received: 1981-02-02
Regulation: 874.5220
Classification name: Syringe, Ent
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 KCP#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K840311	CAT. 7-EAR, NOSE & THROAT DEVICES	Imm Enterprises , Ltd.	1984-05-09
K822754	EAR/ULCER SYRINGE	American Hospital Supply Corp.	1982-10-04
K780599	SYRINGE, EAR & ULCER	Abco Dealers, Inc.	1978-04-19