ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)


Device Classification Name

dressing,wound,occlusive

510(k) Number K072560
Device Name ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
Applicant
TEIKOKU PHARMA USA, INC.
1718 ringwood ave.
san jose, 
CA 
95131 -1711

Applicant Contact margie nemcik-cruz
Correspondent
TEIKOKU PHARMA USA, INC.
1718 ringwood ave.
san jose, 
CA 
95131 -1711

Correspodent Contact margie nemcik-cruz
Regulation Number 878.4020
Classification Product Code
NAD  
Date Received 09/11/2007
Decision Date 06/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No