UNMIAX LAPAROSCOPIC INSTRUMENT


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K103508
Device Name UNMIAX LAPAROSCOPIC INSTRUMENT
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 878.4400
Classification Product Code
GEI  
Date Received 11/29/2010
Decision Date 12/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No