SOFTPAP CERVICAL CELL COLLECTOR


Device Classification Name

spatula, cervical, cytological

510(k) Number K072381
Device Name SOFTPAP CERVICAL CELL COLLECTOR
Applicant
CYTOCORE, INC.
414 north orlean
suite 502
chicago, 
IL 
60610

Applicant Contact richard domanik
Correspondent
CYTOCORE, INC.
414 north orlean
suite 502
chicago, 
IL 
60610

Correspodent Contact richard domanik
Regulation Number 884.4530
Classification Product Code
HHT  
Date Received 08/24/2007
Decision Date 01/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No