OXYGENATOR


information about

Device Classification Name

chamber, oxygen, topical, extremity

510(k) Number K002632
Device Name OXYGENATOR
Original Applicant
ADJUNCTIVE THERAPEUTICS, INC.
10 scotch mist court
potomac, 
MD 
20854

Original Contact myron z bernstein
Regulation Number 878.5650
Classification Product Code
KPJ  
Date Received 08/23/2000
Decision Date 10/25/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No