RADIO BIOAQUACARE


Device Classification Name

dressing, wound, drug

510(k) Number K080471
Device Name RADIO BIOAQUACARE
Applicant
BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC
555 thirteenth street, nw
washington, 
DC 
20004

Applicant Contact jonathan kahan
Correspondent
BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC
555 thirteenth street, nw
washington, 
DC 
20004

Correspodent Contact jonathan kahan
Classification Product Code
FRO  
Date Received 02/21/2008
Decision Date 03/05/2008
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes