THE ESPINER SAC OR E SAC


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K111845
Device Name THE ESPINER SAC OR E SAC
Applicant
ESPINER MEDICAL LIMITED
116 almond road, cumbernauld
glasgow, 

GB

g673lw

Applicant Contact edwin lindsay
Correspondent
ESPINER MEDICAL LIMITED
116 almond road, cumbernauld
glasgow, 

GB

g673lw

Correspodent Contact edwin lindsay
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 06/29/2011
Decision Date 09/26/2011
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