REPROCESSED ELECTROPHYSIOLOGY CATHETER


Device Classification Name

catheter, recording, electrode, reprocessed

510(k) Number K030026
Device Name REPROCESSED ELECTROPHYSIOLOGY CATHETER
Original Applicant
ALLIANCE MEDICAL CORP.
10232 south 51st st.
phoenix, 
AZ 
85044

Original Contact moira barton
Regulation Number 870.1220
Classification Product Code
NLH  
Subsequent Product Code
DSA  
Date Received 01/03/2003
Decision Date 05/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No