ULTRA-CBX


Device Classification Name

device, biopsy, endomyocardial

510(k) Number K991486
Device Name ULTRA-CBX
Applicant
MEDCANICA, INC.
19526 east lake dr.
miami, 
FL 
33015

Applicant Contact al weisenborn
Correspondent
MEDCANICA, INC.
19526 east lake dr.
miami, 
FL 
33015

Correspodent Contact al weisenborn
Regulation Number 870.4075
Classification Product Code
DWZ  
Date Received 04/28/1999
Decision Date 11/05/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No