CORELEADER SCAR-DIMMER


Device Classification Name

elastomer, silicone, for scar management

510(k) Number K111733
Device Name CORELEADER SCAR-DIMMER
Applicant
CORELEADER BIOTECH CO., LTD.
19f no. 100, sec 1
sintai 5th rd, sijhih dist
new taipei, taiwan, 

TW

22102

Applicant Contact ian li
Correspondent
CORELEADER BIOTECH CO., LTD.
19f no. 100, sec 1
sintai 5th rd, sijhih dist
new taipei, taiwan, 

TW

22102

Correspodent Contact ian li
Regulation Number 878.4025
Classification Product Code
MDA  
Date Received 06/21/2011
Decision Date 09/22/2011
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