ENDODRAPE(TM)


Device Classification Name

drape, surgical

510(k) Number K080341
Device Name ENDODRAPE(TM)
Applicant
VORTEK SURGICAL, LLC
1426 w. 29th st. suite 300
indianapolis, 
IN 
46208

Applicant Contact thomas szymczak
Correspondent
VORTEK SURGICAL, LLC
1426 w. 29th st. suite 300
indianapolis, 
IN 
46208

Correspodent Contact thomas szymczak
Regulation Number 878.4370
Classification Product Code
KKX  
Date Received 02/08/2008
Decision Date 07/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No