MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY


Device Classification Name

dressing, wound, drug

510(k) Number K110546
Device Name MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY
Applicant
DERMA SCIENCES, INC.
11440 w. bernardo court,
suite 300
san diego, 
CA 
92127

Applicant Contact ronald s warren
Correspondent
DERMA SCIENCES, INC.
11440 w. bernardo court,
suite 300
san diego, 
CA 
92127

Correspodent Contact ronald s warren
Classification Product Code
FRO  
Date Received 02/25/2011
Decision Date 07/27/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes