OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES


Device Classification Name

pulse-generator, pacemaker, external

510(k) Number K022939
Device Name OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES
Original Applicant
OSYPKA MEDICAL, INC.
7463 draper ave.
la jolla, 
CA 
92037

Original Contact markus j osypka
Regulation Number 870.3600
Classification Product Code
DTE  
Date Received 09/04/2002
Decision Date 10/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No