NOCC HYDROPHILIC WOUND DRESSING


Device Classification Name

dressing, wound, drug

510(k) Number K080010
Device Name NOCC HYDROPHILIC WOUND DRESSING
Applicant
KYTOGENICS, INC
466 southern blvd.
adams building, first floor
chatham, 
NJ 
07928

Applicant Contact marina zazanis
Correspondent
KYTOGENICS, INC
466 southern blvd.
adams building, first floor
chatham, 
NJ 
07928

Correspodent Contact marina zazanis
Classification Product Code
FRO  
Date Received 01/03/2008
Decision Date 03/14/2008
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes