510(k) K833866

Device: Ace/kyle Self Tapping Cannulated Tita
Applicant: BUCKMAN CO., INC.
510(k) number: K833866
Product code: JPW
Decision: Substantially Equivalent (SESE)
Decision date: 1983-12-27
Date received: 1983-11-07
Regulation: 874.5220
Classification name: Pump, Nebulizer, Electrically Powered
Medical specialty: Ear, Nose, Throat
Review panel: Ear, Nose, Throat
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#

Source Documents#

510(k) summary PDF not indicated by FDA