TL-CERMIDE SKIN BARRIER EMULSION


Device Classification Name

dressing, wound, drug

510(k) Number K110757
Device Name TL-CERMIDE SKIN BARRIER EMULSION
Applicant
TRIGEN LABORATORIES, INC.
248 latitude lane
suite 104
lake wylie, 
SC 
29710

Applicant Contact george mccauley
Correspondent
TRIGEN LABORATORIES, INC.
248 latitude lane
suite 104
lake wylie, 
SC 
29710

Correspodent Contact george mccauley
Classification Product Code
FRO  
Date Received 03/18/2011
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No