ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR


Device Classification Name

drape, surgical

510(k) Number K010711
Device Name ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR
Original Applicant
ADVANCED SURGICAL CONCEPTS (ASC)
49 plain st.
north attleboro, 
MA 
02760

Original Contact mary mcnamara-cullinane
Regulation Number 878.4370
Classification Product Code
KKX  
Date Received 03/09/2001
Decision Date 05/22/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No