BENACEL, MODELS C-001, C-002 AND C-005


Device Classification Name

dressing, wound, drug

510(k) Number K080532
Device Name BENACEL, MODELS C-001, C-002 AND C-005
Applicant
UNICARE BIOMEDICAL, INC.
22971-b triton way
laguna hills, 
CA 
92653

Applicant Contact stan yang
Correspondent
UNICARE BIOMEDICAL, INC.
22971-b triton way
laguna hills, 
CA 
92653

Correspodent Contact stan yang
Classification Product Code
FRO  
Date Received 02/26/2008
Decision Date 11/12/2008
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No