HEMOSORB


Device Classification Name

dressing, wound, drug

510(k) Number K021581
Device Name HEMOSORB
Original Applicant
ON SITE GAS SYSTEMS, INC.
35 budney rd.
newington, 
CT 
06111

Original Contact francis x hursey
Classification Product Code
FRO  
Date Received 05/14/2002
Decision Date 07/12/2002
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No