UNIMAX TROCAR SYSTEM


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K112358
Device Name UNIMAX TROCAR SYSTEM
Applicant
UNIMAX MEDICAL SYSTEMS, INC.
no. 45, minshen rd.
danshui town
taipei county, 

TW

251

Applicant Contact michael lee
Correspondent
UNIMAX MEDICAL SYSTEMS, INC.
no. 45, minshen rd.
danshui town
taipei county, 

TW

251

Correspodent Contact michael lee
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 08/16/2011
Decision Date 10/17/2011
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