NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP


Device Classification Name

chamber, oxygen, topical, extremity

510(k) Number K112634
Device Name NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
Applicant
INOTEC AMD LTD.
2995 steven martin dr.
fairfax, 
VA 
22031

Applicant Contact diane horwitz
Correspondent
INOTEC AMD LTD.
2995 steven martin dr.
fairfax, 
VA 
22031

Correspodent Contact diane horwitz
Regulation Number 878.5650
Classification Product Code
KPJ  
Date Received 09/09/2011
Decision Date 07/03/2012
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