UNIMAX ANTI-FOG SOLUTION


Device Classification Name

endoscope and/or accessories

510(k) Number K111622
Device Name UNIMAX ANTI-FOG SOLUTION
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
KOG  
Date Received 06/10/2011
Decision Date 09/09/2011
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