OXYBOX SYSTEM


Device Classification Name

chamber, oxygen, topical, extremity

510(k) Number K023456
Device Name OXYBOX SYSTEM
Original Applicant
OXYFAST CORPORATION
11000 cedar ave # 449
cleveland, 
OH 
44106

Original Contact melvyn burke
Regulation Number 878.5650
Classification Product Code
KPJ  
Date Received 10/15/2002
Decision Date 02/24/2003
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

Recalls CDRH Recalls