CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS)


Device Classification Name

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

510(k) Number K072518
Device Name CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS)
Applicant
CRS MEDICAL DIAGNOSTICS INC.
po box 7007
deerfield, 
IL 
60015

Applicant Contact daniel kamm
Correspondent
CRS MEDICAL DIAGNOSTICS INC.
po box 7007
deerfield, 
IL 
60015

Correspodent Contact daniel kamm
Regulation Number 880.5970
Classification Product Code
LJS  
Date Received 09/07/2007
Decision Date 12/20/2007
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