IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS


Device Classification Name

dialyzer, capillary, hollow fiber

510(k) Number K991908
Device Name IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
Applicant
IDEMSA
1600 stewart ave.
westbury, 
NY 
11590

Applicant Contact leon lachman
Correspondent
IDEMSA
1600 stewart ave.
westbury, 
NY 
11590

Correspodent Contact leon lachman
Regulation Number 876.5820
Classification Product Code
FJI  
Date Received 06/07/1999
Decision Date 04/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No