OCTOTMPORT


Device Classification Name

laparoscopic single port access device

510(k) Number K112196
Device Name OCTOTMPORT
Applicant
DALIM SURGNET CORPORATION
325 n puente st.
unit b
brea, 
CA 
92821

Applicant Contact april lee
Correspondent
DALIM SURGNET CORPORATION
325 n puente st.
unit b
brea, 
CA 
92821

Correspodent Contact april lee
Regulation Number 876.1500
Classification Product Code
OTJ  
Date Received 08/01/2011
Decision Date 09/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No