CROSSEAL APPLICATION DEVICE


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K030032
Device Name CROSSEAL APPLICATION DEVICE
Original Applicant
OMRIX BIOPHARMACEUTICALS, INC.
6599 commerce court
suite 200
warrington, 
VA 
20187

Original Contact sue bhadare
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 01/03/2003
Decision Date 03/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls