MEDOVATIONS ESOPHAGEAL DILATOR


definition

Device Classification Name

dilator, esophageal

510(k) Number K002363
Device Name MEDOVATIONS ESOPHAGEAL DILATOR
Original Applicant
MEDOVATIONS, INC.
1294 barclay blvd.
buffalo grove, 
IL 
60089

Original Contact michael j brown
Regulation Number 876.5365
Classification Product Code
KNQ  
Date Received 08/03/2000
Decision Date 11/01/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No