NEOSCI MEDICAL ENDOLUMINAL BRUSH


Device Classification Name

catheter,intravascular,therapeutic,long-term greater than 30 days

510(k) Number K030400
Device Name NEOSCI MEDICAL ENDOLUMINAL BRUSH
Applicant
NEOSCI MEDICAL, INC.
148 s. 1200 e.
salt lake city, 
UT 
84102

Applicant Contact phil triolo
Correspondent
NEOSCI MEDICAL, INC.
148 s. 1200 e.
salt lake city, 
UT 
84102

Correspodent Contact phil triolo
Regulation Number 880.5970
Classification Product Code
LJS  
Date Received 02/06/2003
Decision Date 12/22/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No