HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM


Device Classification Name

chamber, oxygen, topical, extremity

510(k) Number K080966
Device Name HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM
Applicant
AOTI LTD.
qualtech house
parkmore business park west
galway, 

IE

Applicant Contact robbie walsh
Correspondent
AOTI LTD.
qualtech house
parkmore business park west
galway, 

IE

Correspodent Contact robbie walsh
Regulation Number 878.5650
Classification Product Code
KPJ  
Date Received 04/04/2008
Decision Date 08/06/2008
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