RADLITE TISSUE RETRACTOR SYSTEM


Device Classification Name

light, surgical, endoscopic

510(k) Number K022989
Device Name RADLITE TISSUE RETRACTOR SYSTEM
Original Applicant
GENZYME BIOSURGERY
600 airport rd.
fall river, 
MA 
02720 -4740

Original Contact karen k sylvia
Regulation Number 878.4580
Classification Product Code
FSW  
Date Received 09/09/2002
Decision Date 11/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No