GELSPRAY WOUND DRESSING


Device Classification Name

bandage, liquid

510(k) Number K073663
Device Name GELSPRAY WOUND DRESSING
Applicant
BIOCURE, INC.
20310 sw 48th street
southwest ranches, 
FL 
33332

Applicant Contact john greenbaum
Correspondent
BIOCURE, INC.
20310 sw 48th street
southwest ranches, 
FL 
33332

Correspodent Contact john greenbaum
Regulation Number 880.5090
Classification Product Code
KMF  
Date Received 12/26/2007
Decision Date 01/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No