AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER


Device Classification Name

clip, aneurysm

510(k) Number K024349
Device Name AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
Original Applicant
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Original Contact matthew m hull
Regulation Number 882.5200
Classification Product Code
HCH  
Subsequent Product Code
HCI  
Date Received 12/30/2002
Decision Date 03/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No