STASILON FR


Device Classification Name

dressing, wound, drug

510(k) Number K072890
Device Name STASILON FR
Applicant
ENTEGRION, INC.
79 tw alexander drive suite 20
4401 research commons
research triangle park, 
NC 
27709

Applicant Contact e.s. eskridge, jr.
Correspondent
ENTEGRION, INC.
79 tw alexander drive suite 20
4401 research commons
research triangle park, 
NC 
27709

Correspodent Contact e.s. eskridge, jr.
Classification Product Code
FRO  
Date Received 10/10/2007
Decision Date 12/10/2007
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No