LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE


information about

Device Classification Name

device, monitoring, intracranial pressure

510(k) Number K002765
Device Name LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
Original Applicant
INTEGRA NEUROSCIENCES
5955 pacific center blvd.
san diego, 
CA 
92121

Original Contact nancy mathewson
Regulation Number 882.1620
Classification Product Code
GWM  
Date Received 09/05/2000
Decision Date 11/24/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls