SURGICAL RETRACTORS


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K112659
Device Name SURGICAL RETRACTORS
Applicant
SURGICAL INNOVATIONS PLC
clayton wood house,
6 clayton wood bank
leeds, west yorkshire, 

GB

ls16 6zq

Applicant Contact stephen seed
Correspondent
SURGICAL INNOVATIONS PLC
clayton wood house,
6 clayton wood bank
leeds, west yorkshire, 

GB

ls16 6zq

Correspodent Contact stephen seed
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 09/13/2011
Decision Date 03/09/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No