UNIMAX VERESS NEEDLE


Device Classification Name

insufflator, laparoscopic

510(k) Number K111441
Device Name UNIMAX VERESS NEEDLE
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 884.1730
Classification Product Code
HIF  
Subsequent Product Code
FHO  
Date Received 05/24/2011
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No